TSRH® SPINAL SYSTEM M708348B436E Rev. A
2014-12-22
PURPOSE
The TSRH® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to
fusion of the thoracic, lumbar, and/or sacral spine.
DESCRIPTION
The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, staples, plates,
and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked
into a variety of configurations, with each construct being tailor-made for the individual case.
A subset of TSRH
constructs may be comprised of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK
connecting components as well as CD HORIZON
Multi-Span
®
implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being
tailored-made for the individual case. All screws used in pediatric cases are only cleared for use via a posterior approach. All of
the components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy,
and medical grade cobalt-chromium-molybdenum alloy.
®
TSRH
Spinal System staples, unit rods, s-rods and 7.0mm diameter rods are specifically excluded for use in pediatric patients.
Certain implant components from other Medtronic spinal systems can be used with the TSRH
components. These components include GDLH
screws; DYNALOK
The hooks are intended for posterior use only. The staples are for anterior use only. The TSRH-3D
connectors, and TSRH-3D® and TSRH® 3DxTM screws are intended for posterior use only. Within the TSRH® family, the cobalt
chromium rods should only be used with TSRH
CROSSLINK
The TSRH
®
titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy. Medical grade titanium, titanium alloy, and/or cobaltchromium-molybdenum alloy may be used together. Certain TSRH
hydroxyapatite. Never use titanium, titanium alloy, and/or cobalt-chromium-molybdenum alloy with stainless steel in the
same construct.
No warranties, express, or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use
are specifically excluded.
To achieve best results, do not use any of the TSRH
system, except those components listed above, or any other manufacturer. As with all orthopaedic and neurosurgical implants,
none of the TSRH
®
Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These
®
Spinal System components cleared for pediatric use such as Low Profile
Crosslink® Plates and CD HORIZON® rods, screws, set screws and locking screws. Similarly to the TSRH
®
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PLUS bolts, and, VANTAGE™ Anterior Fixation System screws.
®
Axial and Offset Plates may be used anteriorly as well.
rods, rod/bolt connectors, Variable Angle T-bolts, set screws and locking
®
3DxTM Spinal System. All CROSSLINK® Plates are for posterior use and the
®
Plates, plates, and
®
®
Spinal System in non-pediatric
®
and TSRH® 3Dx
TM
Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium or
®
Spinal System components may be coated with
®
Spinal System implant components with components from any other
®
Spinal System components should ever be reused under any circumstances.
INDICATIONS
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using allograft
and/or autograft, the TSRH
degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history
and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4)
dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the TSRH
skeletally mature patients using allograft and/or autograft: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth
lumbar-first sacral (L5-S1) vertebral joint: (2) who are receiving fusions using autogenous bone graft only: (3) who are having
the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the
development of a solid fusion mass.
®
Spinal System is indicated as an adjunct to fusion for one or more of the following: (1)
®
Spinal System is indicated as an adjunct to fusion for
When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the
following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc
confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis,
kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts
at spinal fusion.
When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region, the TSRH
VANTAGE
stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
For anterior use only the TSRH
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the TSRH
indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The TSRH
used with allograft and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
TM
screws are intended for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal
®
Spinal System has the additional indication of: spondylolysis.
®
®
Pediatric Spinal System is intended to be
Spinal System implants are
®
L-Plate and
CONTRAINDICATIONS
Contraindications include, but are not limited to:
▪ Active infectious process or significant risk of infection (immunocompromise).
▪ Signs of local inflammation.
▪ Fever or leukocytosis.
▪ Morbid obesity.
▪ Pregnancy.
▪ Mental illness.
▪ Grossly distorted anatomy caused by congenital abnormalities.
▪ Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the
presence of congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white
blood count (WBC), or a marked left shift in the WBC differential count.
▪ Suspected or documented metal allergy or intolerance.
▪ Any case not needing a bone graft and fusion.
▪ Any case where the implant components selected for use would be too large or too small to achieve a successful result.
▪ Any case that requires the mixing of metals from two different components or systems.
▪ Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
▪ Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance.
▪ Any patient unwilling to follow postoperative instructions.
▪ Any case not described in the indications.
NOTA BENE: Although not absolute contraindications, conditions to be considered as potential factors for not using
this device include:
▪ Severe bone resorption.
▪ Osteomalacia
▪ Severe osteoporosis.
POTENTIAL ADVERSE EVENTS
All of the possible adverse events associated with spinal fusion surgery without instrumentation are possible. With
instrumentation, a listing of potential adverse events includes, but is not limited to:
▪ Early or late loosening of any or all of the components.
▪ Disassembly, bending, and/or breakage of any or all of the components.
▪ Foreign body (allergic) reaction to implants, debris, corrosion products (from crevice, fretting, and/or general corrosion),
including metallosis, staining, tumor formation, and/or autoimmune disease.
▪ Pressure on the skin from component parts in patients with inadequate tissue coverage over the implant possibly causing
skin penetration, irritation, fibrosis, necrosis, and/or pain.
▪ Bursitis and tissue or nerve damage caused by improper positioning and placement of implants or instruments.
▪ Post-operative change in spinal curvature, loss of correction, height, and/or reduction.
▪ Infection.
▪ Dural tears, pseudomeningocele, fistula, persistent CSF leakage, meningitis.
▪ Loss of neurological function (e.g., sensory and/or motor), including paralysis (complete or incomplete), dysesthesias,
hyperesthesia, anesthesia, paresthesia, appearance of radiculopathy, and/or the development or continuation of pain,
numbness, neuroma, spasms, sensory loss, tingling sensation, and/or visual deficits.
▪ Cauda equina syndrome, neuropathy, neurological deficits (transient or permanent), paraplegia, paraparesis, reflex deficits,
irritation, arachnoiditis, and/or muscle loss.
▪ Urinary retention or loss of bladder control or other types of urological system compromise.
▪ Scar formation possibly causing neurological compromise or compression around nerves and/or pain.
▪ Fracture, microfracture, resorption, damage, or penetration of any spinal bone (including the sacrum, pedicles, and/or
vertebral body) and/or bone graft or bone graft harvest site at, above, and/or below the level of surgery.
▪ Retropulsed graft.
▪ Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of surgery.
▪ Non-union (or pseudarthrosis), delayed union, and mal-union.
▪ Cessation of any potential growth of the operated portion of the spine.
▪ Loss of or increase in spinal mobility or function.
▪ Inability to perform the activities of daily living.
▪ Bone loss or decrease in bone density, possibly caused by stress shielding.
▪ Graft donor site complications including pain, fracture, or wound healing problems.
▪ Ileus, gastritis, bowel obstruction or loss of bowel control or other types of gastrointestinal system compromise.
▪ Hemorrhage, hematoma, occlusion, seroma, edema, hypertension, embolism, stroke, excessive bleeding, phlebitis, wound
necrosis, wound dehiscence, damage to blood vessels, or other types of cardiovascular system compromise.
▪ Reproductive system compromise, including sterility, loss of consortium, and sexual dysfunction.
▪ Development of respiratory problems, e.g. pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.
▪ Change in mental status.
▪ Death.
Note: Additional surgery may be necessary to correct some of these potential adverse events.
ADDITIONAL POTENTIAL ADVERSE EVENTS FOR PEDIATRIC PATIENTS
▪ Inability to use pedicle screw fixation due to anatomic limitations (pedicle dimensions, distorted anatomy)
▪ Pedicle screw malpositioning, with or without neurological or vascular injury
▪ Proximal or distal junctional kyphosis
▪ Pancreatitis
WARNINGS
The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant
mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability
or deformity of the thoracic, lumbar, and sacral spine secondary to degenerative spondylolisthesis with objective evidence of
neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The
safety and effectiveness of this device for any other conditions are unknown.
This device was designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing,
or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which
could result in patient injury, illness, or death.
ADDITIONAL WARNINGS FOR PEDIATRIC PATIENTS
Warning: The safety and effectiveness of this device has not been established for use as part of a growing rod construct. This
device is only intended to be used when definitive fusion is being performed at all instrumented levels.
The use of pedicle screw fixation in the pediatric population may present additional risks when patients are of smaller stature
and skeletally immature. Pediatric patients may have smaller spinal structures (pedicle diameter or length) that may preclude
the use of pedicle screws or increase the risk of pedicle screw malpositioning and neurological or vascular injury. Patients not
skeletally mature that undergo spinal fusion procedures may have reduced longitudinal spinal growth, or may be at risk for
rotational spinal deformities (the “crankshaft phenomenon”) due to continued differential growth of the anterior spine.
Other adverse events related to pedicle screw fixation, such as screw or rod bending, breakage, or loosening, may also occur in
pediatric patients. Pediatric patients may be at increased risk for device-related injury because of their smaller stature.
PRECAUTION(S)
The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific
training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of
serious injury to the patient.
A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where many
extenuating circumstances may compromise the results. This device system is not intended to be the sole means of spinal
support. Use of this product without a bone graft or in cases that develop into a non-union will not be successful. No spinal
implant can withstand body loads without the support of bone. In this event, bending, loosening, disassembly, and/or breakage
of the device(s) will eventually occur.
Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and proper selection and
placement of the implants are important considerations in the successful utilization of the system by the surgeon. Further, the
proper selection and compliance of the patient will greatly affect the results. Patients who smoke have been shown to have an
increased incidence of non-unions. These patients should be advised of this fact and warned of this consequence. Obese,
malnourished, and/or alcohol abuse patients are also poor candidates for spine fusion. Patients with poor muscle and bone
quality and/or nerve paralysis are also poor candidates for spine fusion.
ADDITIONAL PRECAUTIONS FOR PEDIATRIC PATIENTS
The implantation of pedicle screw spinal systems in pediatric patients should be performed only by experienced spinal surgeons
with specific training in the use of this pedicle screw spinal system in pediatric patients because this is a technically demanding
procedure presenting a risk of serious injury to the patient.
Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and proper selection and
placement of the implants are important considerations in the successful utilization of the system in pediatric patients.
The selection of the proper size, shape, and design of the implant for each patient is crucial to the safe use of this
device in pediatric patients.
PHYSICIAN NOTE: Although the physician is the learned intermediary between the company and
the patient, the important medical information given in this document should be conveyed to the
patient.
For US Audiences Only
CAUTION: FEDERAL LAW (USA) RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER
OF A PHYSICIAN.
Other preoperative, intraoperative, and postoperative warnings and precautions are as follows:
MAGNETIC RESONANCE SAFETY
The TSRH® Spinal System has not been evaluated for safety, heating, migration, or compatibility in the magnetic resonance
environment.
IMPLANT SELECTION
The selection of the proper size, shape, and design of the implant for each patient is crucial to the success of the procedure.
Metallic surgical implants are subject to repeated stresses in use, and their strength is limited by the need to adapt the design to
the size and shape of human bones. Unless great care is taken in patient selection, proper placement of the implant, and
postoperative management to minimize stresses on the implant, such stresses may cause metal fatigue and consequent
breakage, bending or loosening of the device before the healing process is complete, which may result in further injury or the
need to remove the device prematurely.
PREOPERATIVE
▪ Only patients that meet the criteria described in the indications should be selected.
▪ Patient conditions and/or predispositions such as those addressed in the aforementioned contraindications should be
avoided.
▪ Care should be used in the handling and storage of the implant component. The implants should not be scratched or
otherwise damaged. Implants and instruments should be protected during storage, especially from corrosive environments.
▪ An adequate inventory of implants should be available at the time of surgery, normally a quantity in excess of what is
expected to be used.
▪ Since mechanical parts are involved, the surgeon should be familiar with the various components before using the
equipment and should personally assemble the devices to verify that all parts and necessary instruments are present before
the surgery begins. The TSRH
combined with the components from another manufacturer. Different metal types should never be used together.
®
Spinal System components (described in the DESCRIPTION section) are not to be
▪ All components and instruments should be cleaned and sterilized before use. Additional sterile components should be
available in case of an unexpected need.
INTRAOPERATIVE
▪ Extreme caution should be used around the spinal cord and nerve roots. This admonition is especially true when inserting
hooks and screws. Damage to the nerves will cause loss of neurological functions.
▪ Breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel.
▪ The rods should not be repeatedly or excessively bent. The rods should not be reverse bent in the same location. Use great
care to ensure that the implant surfaces are not scratched or notched, since such actions may reduce the functional
strength of the construct. If the rods are cut to length, they should be cut in such a way as to create a flat, non-sharp surface
perpendicular to the midline of the rod. Cut the rods outside the operative field. Whenever possible, pre-cut rods of the
length needed.
▪ Do not use the TSRH
trial or other nearby hardware may suddenly change position, possibly causing damage or injury.
®
hook trials in any type of prying action. The trial may bend or break, especially at the tip. Also, the
▪ Whenever possible or necessary, an imaging system should be utilized to facilitate surgery.
▪ To insert a screw properly, a guide wire should first be used, followed by a sharp tap. Caution: Do not overtap or use a
screw/bolt that is either too long or too large. Overtapping or using an incorrectly sized screw/bolt may cause nerve
damage, hemorrhage, or the other possible adverse events listed elsewhere in this package insert. If screws/bolts are being
inserted into spinal pedicles, use as large a screw/bolt diameter as will fit into each pedicle.
▪ Bone graft must be placed in the area to be fused and graft material must extend from the upper to the lower vertebrae
being fused.
▪ To ensure maximum stability, two or more CROSSLINK
whenever possible.
®
plates on two bilaterally placed, continuous rods should be used
▪ Bone cement should not be used because the safety and effectiveness of bone cement has not been determined for spinal
uses, and this material will make removal of the components difficult or impossible. The heat generated from the curing
process may also cause neurologic damage and bone necrosis.
▪ Before closing the soft tissues, provisionally tighten (finger tighten) all of the nuts or screws, especially screws or nuts that
have a break-off feature. Once this is completed go back and firmly tighten all of the screws and nuts. Recheck the
tightness of all nuts or screws after finishing making sure that none loosened during the tightening of the other nuts or
screws. Failure to do so may cause loosening of the other components.
POSTOPERATIVE
The physician’s postoperative directions and warnings to the patient, and the corresponding patient compliance, are extremely
important.
▪ Detailed instructions on the use and limitations of the device should be given to the patient. If partial weight-bearing is
recommended or required prior to firm bony union, the patient must be warned that bending, loosening, and/or breakage of
the device(s) are complications which may occur as a result of excessive or early weight-bearing or muscular activity. The
risk of bending, loosening, or breakage of a temporary internal fixation device during postoperative rehabilitation may be
increased if the patient is active, or if the patient is debilitated or demented. The patient should be warned to avoid falls or
sudden jolts in spinal position.
▪ To allow the maximum chances for a successful surgical result, the patient or devices should not be exposed to mechanical
vibrations or shock that may loosen the device construct. The patient should be warned of this possibility and instructed to
limit and restrict physical activities, especially lifting and twisting motions and any type of sport participation. The patient
should be advised not to smoke tobacco or utilize nicotine products, or to consume alcohol or non-steroidal or antiinflammatory medications such as aspirin during the bone graft healing process.
▪ The patient should be advised of their inability to bend or rotate at the point of spinal fusion and taught to compensate for
this permanent physical restriction in body motion.
▪ Failure to immobilize a delayed or non-union of bone will result in excessive and repeated stresses on the implant. By the
mechanism of fatigue, these stresses can cause the eventual bending, loosening, or breakage of the device(s). It is
important that immobilization of the spinal surgical site be maintained until firm bony union is established and confirmed by
roentgenographic examination. If a state of non-union persists or if the components loosen, bend, and/or break, the
device(s) should be revised and/or removed immediately before serious injury occurs. The patient must be adequately
warned of these hazards and closely supervised to insure cooperation until bony union is confirmed.
▪ As a precaution, before patients with implants receive any subsequent surgery (such as dental procedures), prophylactic
antibiotics may be considered, especially for high risk patients.
▪ The TSRH
stabilize the operative site during the normal healing process. After the spine is fused, these devices serve no functional
purpose and may be removed. While the final decision on implant removal is, of course, up to the surgeon and patient, in
most patients removal is indicated because the implants are not intended to transfer or support forces developed during
normal activities. If the device is not removed following completion of its intended use, one or more of the following
complications may occur: (1) Corrosion, with localized tissue reaction or pain; (2) Migration of implant position, possibly
resulting in injury; (3) Risk of additional injury from postoperative trauma; (4) Bending, loosening, and breakage which could
make removal impractical or difficult; (5) Pain, discomfort, or abnormal sensations due to the presence of the device; (6)
Possible increased risk of infection; (7) Bone loss due to stress shielding; and (8) Potential unknown and/or unexpected
long term effects such as carcinogenesis. Implant removal should be followed by adequate postoperative management to
avoid fracture, re-fracture, or other complications.
®
Spinal System implants are temporary internal fixation devices. Internal fixation devices are designed to
▪ Any retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible. As with
all orthopedic implants, the TSRH
®
Spinal System components should never be reused under any circumstances.
PACKAGING
Packages for each of the components should be intact upon receipt. If a loaner or consignment system is used, all sets should
be carefully checked for completeness and all components including instruments should be carefully checked to ensure that
there is no damage prior to use. Damaged packages or products should not be used, and should be returned to MEDTRONIC.
CLEANING AND DECONTAMINATION
Unless just removed from an unopened MEDTRONIC package, all instruments and implants must be disassembled (if
applicable) and cleaned using neutral cleaners before sterilization, introduction into a sterile surgical field, or (if applicable)
return of the product to MEDTRONIC. Cleaning and disinfecting of instruments can be performed with aldehyde-free solvents at
higher temperatures. Cleaning and decontamination must include the use of neutral cleaners followed by a deionized water
rinse. Cleaning instructions and associated disassembly instructions (if applicable) can be found at
manuals.
NOTE: Certain cleaning solutions such as those containing formalin, glutaraldehyde, bleach and/or other alkaline cleaners may
damage some devices, particularly instruments. These solutions should
Cleaning and Sterilization Quick Reference Guide part number 0381424. Also, many instruments require disassembly before
cleaning.
All products should be treated with care. Improper use or handling may lead to damage and/or possible improper functioning of
the device.
not be used unless instructed by the Instrument Care,
www.medtronic.com/
STERILIZATION
Unless marked sterile and clearly labeled as such in an unopened sterile package provided by the company, all implants and
instruments used in surgery
must be sterilized by the hospital prior to use. Remove all packaging materials prior to sterilization.
Only sterile products should be placed in the operative field. Unless specified elsewhere, these products are recommended to
be steam sterilized by the hospital using one of the sets of process parameters below:
Table 1: In the United States and its territories:
METHOD CYCLE TEMPERATURE EXPOSURE TIME DRY TIME
Steam Pre-Vacuum 270°F (132°C) 4 Minutes 30 minutes
Steam Gravity 250°F (121°C) 60 Minutes 30 minutes
For Medical Facilities Located Outside the United States and its territories: Some non-U.S. Health Care Authorities
recommend sterilization according to these parameters so as to minimize the potential risk of transmission of Creutzfeldt-Jakob
disease, especially of surgical instruments that could come into contact with the central nervous system.
METHOD CYCLE TEMPERATURE EXPOSURE TIME DRY TIME
Steam Pre-Vacuum 273°F (134°C) 20 Minutes 30 minutes
Steam Gravity 273°F (134°C) 20 Minutes 30 minutes
NOTE: Because of the many variables involved in sterilization, each medical facility should calibrate and verify the sterilization
process (e.g. temperatures, times) used for their equipment. Not all of the sterilization parameters provided above are
considered to be standard cycles according to the Food and Drug Administration (FDA). In the United States, use only sterilizer
accessories that have been cleared by the FDA for the selected sterilization cycle parameters (time and temperature). Users
should only use sterilizer accessories (such as sterilization wraps, sterilization pouches, chemical indicators, and sterilization
cassettes) that have been cleared for use in their markets.
PRODUCT COMPLAINTS
Any health care professional (e.g., customer or user of this system of products), who has any complaints or who has
experienced any dissatisfaction in the product quality, identity, durability, reliability, safety, effectiveness, and/or performance,
should notify the distributor or MEDTRONIC. Further, if any of the implanted spinal system component(s) ever “malfunctions”
(i.e., does not meet any of its performance specifications or otherwise does not perform as intended), or is suspected of doing
so, the distributor should be notified immediately. If any MEDTRONIC PRODUCT ever “malfunctions” and may have caused or
contributed to the death or serious injury of a patient, the distributor should be notified immediately by telephone, fax, or written
correspondence. When filing a complaint, please provide the component(s) name and number, lot number(s), your name and
address, the nature of the complaint, and notification of whether or not a written report from the distributor is requested.
FURTHER INFORMATION
Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If
further information is needed or required, please contact MEDTRONIC.
©
2014 MEDTRONIC SOFAMOR DANEK USA, Inc. All rights reserved.
AUSTRALIAN SPONSOR:
Medtronic Australasia Pty Ltd
97 Waterloo Rd
North Ryde, NSW 2113
Australia
EXPLANATION OF SYMBOLS
Authorized representative in the European Community
CAUTION: Federal law (USA) restricts these devices to sale
by or on the order of a physician.
Do not re-use
Batch code
Manufacturer
Catalogue number
Non-sterile
For US audiences only
The device complies with European Directive MDD 93/42/EEC
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
Telephone: 800 933 2635 (USA)
Telephone: 901 396 3133 (Outside USA)
Fax: 901 396 0356
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00
Consult instructions for use at this website.
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