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Address: Prof.-Kuentscher-Strasse 1-5, Schoenkirchen D-24232, Germany
Phone: +49-(4348)-702-0
FDA Registration: 9610622 Year Established: 1941
Products: Small Depth Gauge (FDA Code:
HTJ), Depth Gauge (FDA Code:
HTJ), Flexible Depth Gauge (FDA Code:
HTJ), Invasive Traction Component (FDA Code:
JEC), Orthopedic Manual Surgical Instrument (FDA Code:
LXH), Pneumatic Powered Orthopedic Surgical Instrument & Accessory (FDA Code:
HSZ), ...
Stryker Trauma GmbH offers orthopedic manual surgical instruments, pneumatic orthopedic power tool systems, screws and staples.
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Address: 1120, Tuttlingen, Donau D-78532, Germany
www.aesculap.de |
Send Inquiry |
Phone: +94-(610)-9849074
FDA Registration: 9610612
Products: Small Depth Gauge (FDA Code:
HTJ), Depth Gauge (FDA Code:
HTJ), Laser Power Probe, Laparoscopic Probes, Guiding Probes, Flexible Depth Gauge (FDA Code:
HTJ), ...
Aesculap Ag offers instruments for minimal invasive surgery. Our product range includes surgical instruments for open or minimally invasive approaches, implants for orthopedic, neuro and spinal surger
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Address: Technopole De L'Aube, Bp2-10902, Cedex 9, Troyes, France
www.ldrmedical.com |
Phone: +33-(03)-25823263
FDA Registration: 3004788213
Products: Calcium Compound Bone Void Filler (FDA Code:
MQV), Spinal Interlaminal Fixation Appliance (FDA Code:
KWP), Spinal Pedicle Fixation Orthosis (FDA Code:
MNI), Spinal Vertebral Body Replacement Device (FDA Code:
MQP), Spondylolisthesis Spinal Fixation Orthosis (FDA Code:
MNH), Spinal Pedicle Fixation Orthosis For Degenerative Disc Disease (FDA Code:
NKB), ...
LDR Medical provides products for both fusion and non-fusion surgery. Our products include Mobi™ artificial disc system, Roi® peek implementation system and Easyspine® pedicle screw syst
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Address: 1-8 Tianshan Road, Xinbei Zone, Changzhou, Jiangsu 213022, China
FDA Registration: 3013682751
Products: Forceps (FDA Code:
HTD), Bone Fixation Nail (FDA Code:
JDS), Intramedullary Fixation Rod and Accessories (FDA Code:
HSB), Spinal Intervertebral Body Fixation Appliance (FDA Code:
KWQ), Spondylolisthesis Spinal Fixation Orthosis (FDA Code:
MNH), Spinal Pedicle Fixation Orthosis For Degenerative Disc Disease (FDA Code:
NKB), ...
Changzhou Kanghui Medical Innovation Co., Ltd. supplies orthopedic products. Our products include bone fixation nails, spinal intervertebral body fixation appliances, intramedullary fixation rod and a
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44 Spinal Pedicle Fixation Orthosis For Degenerative Disc Disease suppliers Page:
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FDA Code / Regulation: NKB / 888.3070 Pedicle screw spinal systems are multiple component devices, made from a variety of materials, including alloys such as 316L stainless steel, 316LVM stainless steel, 22Cr-13Ni-5Mn stainless steel, Ti-6Al-4V, and unalloyed titanium, that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of anchors (e.g., bolts, hooks, and/or screws); interconnection mechanisms incorporating nuts, screws, sleeves, or bolts; longitudinal members (e.g., plates, rods, and/or plate/rod combinations); and/or transverse connectors.
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls: