Spondylolisthesis Spinal Fixation Orthosis Suppliers
Limit companies to: Worldwide USA
Spine Matrix Technologies, LLC | Address: 2647 Cassowary Circle, Crescent, Utah 84092, USA 
Phone: +1-(801)-3380700
Products: Replacement Parts, Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spinal Vertebral Body Replacement Device (FDA Code: MQP), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Spine Matrix Technologies, LLc offers spinal interlaminal fixation appliances, spinal vertebral body replacement devices, spondylolisthesis spinal fixation orthosis and spinal inter-vertebral body fix more...
Phone: +1-(801)-3380700
Products: Replacement Parts, Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spinal Vertebral Body Replacement Device (FDA Code: MQP), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Spine Matrix Technologies, LLc offers spinal interlaminal fixation appliances, spinal vertebral body replacement devices, spondylolisthesis spinal fixation orthosis and spinal inter-vertebral body fix more...
Jemo Spine, LLC | Address: 6170 South 380 West, Suite 200, Murray, Utah 84107, USA
www.jemospine.com | Send Inquiry | Phone: +1-(801)-266-4811
Products: Synthetic Bone Substitute, Anterior Cervical Plate, Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), Spinal Fusion Systems, ...
Jemo Spine, LLC specializes in spinal fusion system. Our Delta™ spinal fusion system employs proprietary technological advancements in poly-axial screw design which aids the surgeon’s plac more...
www.jemospine.com | Send Inquiry | Phone: +1-(801)-266-4811
Products: Synthetic Bone Substitute, Anterior Cervical Plate, Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), Spinal Fusion Systems, ...
Jemo Spine, LLC specializes in spinal fusion system. Our Delta™ spinal fusion system employs proprietary technological advancements in poly-axial screw design which aids the surgeon’s plac more...
Innovasis, Inc. | Address: 614 East 3900 South, Salt Lake City, Utah 84107, USA
www.innovasis.com | Send Inquiry | Phone: +1-(801)-261-2236
FDA Registration: 3004719693
Products: Titanium Plating Systems, Cervical Plate System, Cement Restrictor Hip Prosthesis (FDA Code: JDK), Spinal Fixation Device, Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), ...
Innovasis, Inc. is engaged in the research, development, manufacturing, and marketing of spinal implant devices. We offer a spinal product line with implants and instruments that address major patholo more...
www.innovasis.com | Send Inquiry | Phone: +1-(801)-261-2236
FDA Registration: 3004719693
Products: Titanium Plating Systems, Cervical Plate System, Cement Restrictor Hip Prosthesis (FDA Code: JDK), Spinal Fixation Device, Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), ...
Innovasis, Inc. is engaged in the research, development, manufacturing, and marketing of spinal implant devices. We offer a spinal product line with implants and instruments that address major patholo more...
Amedica Corp. | Address: 1885 West 2100 South, Salt Lake City, Utah 84119, USA
www.amedicacorp.com | Send Inquiry | Phone: +1-(801)-839-3500
FDA Registration: 3005032068
Products: Spinal Spacers, Pedicle Screw System, Cervical Plate System, Orthopedic Manual Surgical Instrument (FDA Code: LXH), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX), ...
Amedica Corp. is engaged in the production of orthopedic implant products. Our products include compact VBR spacer, VBR lumbar spacer, cervical plate system, anterior cervical plate system, pedicle sc more...
www.amedicacorp.com | Send Inquiry | Phone: +1-(801)-839-3500
FDA Registration: 3005032068
Products: Spinal Spacers, Pedicle Screw System, Cervical Plate System, Orthopedic Manual Surgical Instrument (FDA Code: LXH), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX), ...
Amedica Corp. is engaged in the production of orthopedic implant products. Our products include compact VBR spacer, VBR lumbar spacer, cervical plate system, anterior cervical plate system, pedicle sc more...
Kronos Spinal Technologies, Llc | Address: No.1838 E. 9800 South, Sandy, Utah 84092, USA
Phone: +1-(801)-718-7467
Products: Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spinal Vertebral Body Replacement Device (FDA Code: MQP), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Kronos Spinal Technologies, Llc offers spinal interlaminal fixation appliances, spinal intervertebral body fixation appliances, spinal vertebral body replacement devices, spinal pedicle fixation ortho more...
Phone: +1-(801)-718-7467
Products: Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spinal Vertebral Body Replacement Device (FDA Code: MQP), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Kronos Spinal Technologies, Llc offers spinal interlaminal fixation appliances, spinal intervertebral body fixation appliances, spinal vertebral body replacement devices, spinal pedicle fixation ortho more...
Embassy Spinal Technologies | Address: 1838 E. 9800 South, Sandy, Utah 84092, USA
Phone: +1-(801)-718-7467
Products: Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spinal Vertebral Body Replacement Device (FDA Code: MQP), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Embassy Spinal Technologies offers spinal interlaminal fixation appliances, spinal intervertebral body fixation appliances, spinal vertebral body replacement devices, spinal pedicle fixation orthosis more...
Phone: +1-(801)-718-7467
Products: Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spinal Vertebral Body Replacement Device (FDA Code: MQP), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Embassy Spinal Technologies offers spinal interlaminal fixation appliances, spinal intervertebral body fixation appliances, spinal vertebral body replacement devices, spinal pedicle fixation orthosis more...
K2M, Inc. | Address: 751 Miller Dr. S.E., Suite F-1, Leesburg, Virginia 20175, USA
www.k2m.com | Send Inquiry | Phone: +1-(866)-526-4171
FDA Registration: 3004774118
Products: Probes (FDA Code: HXB), Hook, Screw and Rod Systems, Drill Bit (FDA Code: HTW), Bone Taps (FDA Code: HWX), Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), ...
K2M, Inc. specializes in products related to spinal disorders. Our product portfolio includes Mesa® spinal systems, Range® spinal systems, Denali® spinal systems, Serengeti® minimally more...
www.k2m.com | Send Inquiry | Phone: +1-(866)-526-4171
FDA Registration: 3004774118
Products: Probes (FDA Code: HXB), Hook, Screw and Rod Systems, Drill Bit (FDA Code: HTW), Bone Taps (FDA Code: HWX), Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), ...
K2M, Inc. specializes in products related to spinal disorders. Our product portfolio includes Mesa® spinal systems, Range® spinal systems, Denali® spinal systems, Serengeti® minimally more...
Norm Tibbi Urunler Ith. Ihr. San. Ve Tic. Ltd. Sti | Address: 1.Cad. 5/1 Balgat, Ankara, TR-06 06520, Turkey 
Products: Pedicle Screws, Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Norm Tibbi Urunler Ith. Ihr. San. Ve Tic. Ltd. Sti specializes in offering antibacterial silver screw system. It is a pedicle screw system which is used for the treatment of degenerative or pathologic more...
Products: Pedicle Screws, Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Norm Tibbi Urunler Ith. Ihr. San. Ve Tic. Ltd. Sti specializes in offering antibacterial silver screw system. It is a pedicle screw system which is used for the treatment of degenerative or pathologic more...
G Surgical Co., Ltd. | Address: 152 Soi Ramkhamhaeng 138, Sapansung, Bangkok 10240, Thailand
www.gsurgical.com | Phone: +66-(22)-7306288
FDA Registration: 3006378738
Products: Lumbar, Pedicle Screw System, Cervical Plate System, General Surgical Manual Instrument (FDA Code: MDM), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), ...
G Surgical Co., Ltd. deals with medical products. Our products are lumbar and cervical thoracic system. We provide surgical pedicle system, which features a low profile, polyaxial and monoaxial self t more...
www.gsurgical.com | Phone: +66-(22)-7306288
FDA Registration: 3006378738
Products: Lumbar, Pedicle Screw System, Cervical Plate System, General Surgical Manual Instrument (FDA Code: MDM), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), ...
G Surgical Co., Ltd. deals with medical products. Our products are lumbar and cervical thoracic system. We provide surgical pedicle system, which features a low profile, polyaxial and monoaxial self t more...
A-Spine Asia, Co., Ltd | Address: 2f-1., No. 298, Rueiguang Road, Neihu District, Taipei 114, Taiwan 
www.aspine.com.tw | Send Inquiry | Phone: +886-(2)-26272977
Products: Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
A-Spine Asia, Co., Ltd specializes in producing orthopedic products. Our products include vesselplasty, tri-fix system, vertebral disc spacers and USB plate systems. Our TriFix G system is ideal for s more...
www.aspine.com.tw | Send Inquiry | Phone: +886-(2)-26272977
Products: Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
A-Spine Asia, Co., Ltd specializes in producing orthopedic products. Our products include vesselplasty, tri-fix system, vertebral disc spacers and USB plate systems. Our TriFix G system is ideal for s more...
Spineart Sa | Address: 20 Route De Pre Bois, Cp 1813, Geneva 1215, Switzerland
www.spineart.ch | Send Inquiry | Phone: +41-(22)-7994020
FDA Registration: 3007728266
Products: Disc Prosthesis, Spinal Products, Spinal Motion Preservation System, Intersomatic Lumbar Cages, Spine Implants, Interspinous Process Distraction Device, ...
Spineart Sa designs and markets spine patented implants. We provide Baguera® C which is a cervical disc prosthesis that is pre-assembled, & MRI-compatible. Tryptik® CA cervical & Juliet® l more...
www.spineart.ch | Send Inquiry | Phone: +41-(22)-7994020
FDA Registration: 3007728266
Products: Disc Prosthesis, Spinal Products, Spinal Motion Preservation System, Intersomatic Lumbar Cages, Spine Implants, Interspinous Process Distraction Device, ...
Spineart Sa designs and markets spine patented implants. We provide Baguera® C which is a cervical disc prosthesis that is pre-assembled, & MRI-compatible. Tryptik® CA cervical & Juliet® l more...
Depuy Spine Sarl | Address: 36, Chemin Blanc, Lelocle CH-2400, Switzerland
Phone: +41-(32)-7277720
Products: Giardia Spp. (FDA Code: MHI), Cement Mixing Equipment (FDA Code: JDZ), Orthopedic Needle Holder (FDA Code: HXK), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX), ...
Depuy Spine Sarl provides orthopedic needle holders and spinal interlaminal fixation appliances. more...
Phone: +41-(32)-7277720
Products: Giardia Spp. (FDA Code: MHI), Cement Mixing Equipment (FDA Code: JDZ), Orthopedic Needle Holder (FDA Code: HXK), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX), ...
Depuy Spine Sarl provides orthopedic needle holders and spinal interlaminal fixation appliances. more...
Synthes Gmbh | Address: Eimattstrasse 3, Oberdorf CH-4436, Switzerland
www.synthes.com | Send Inquiry | Phone: +41-(61)-9656666
FDA Registration: 8030965
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), ...
Synthes GmbH develops, produces and markets instruments, implants & biomaterials for the surgical fixation, correction & regeneration of the skeleton & its soft tissues. Trauma implants and instrument more...
www.synthes.com | Send Inquiry | Phone: +41-(61)-9656666
FDA Registration: 8030965
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), ...
Synthes GmbH develops, produces and markets instruments, implants & biomaterials for the surgical fixation, correction & regeneration of the skeleton & its soft tissues. Trauma implants and instrument more...
Co-Ligne Ag | Address: Utoquai 43, Zurich CH-8008, Switzerland
www.coligne.com | Send Inquiry | Phone: +41-(43)-343 8000
Products: 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), ...
Co-Ligne Ag specializes in cylindrical fiber reinforced implants. Our proprietary technology built ostaPek carbon compositive VBR system,is an implant system that provides better stability for correct more...
www.coligne.com | Send Inquiry | Phone: +41-(43)-343 8000
Products: 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), ...
Co-Ligne Ag specializes in cylindrical fiber reinforced implants. Our proprietary technology built ostaPek carbon compositive VBR system,is an implant system that provides better stability for correct more...
Medos International Sarl | Address: Chemin-Blanc 38, Le Locle, CH-NE 2400, Switzerland
FDA Registration: 3008114965
Products: General Medical Equipment, Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), Spinal Pedicle Fixation Orthosis For Degenerative Disc Disease (FDA Code: NKB), ...
Medos International Sarl specializes in offering medical & hospital equipment and supplies. more...
FDA Registration: 3008114965
Products: General Medical Equipment, Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), Spinal Pedicle Fixation Orthosis For Degenerative Disc Disease (FDA Code: NKB), ...
Medos International Sarl specializes in offering medical & hospital equipment and supplies. more...
Elite Surgical Supplies (pty) Ltd | Address: 184 Bessemer Rd, Pretoria West, Pretoria 0183, South Africa 
www.elitesurgical.com | Send Inquiry | Phone: +27-(12)-3860012
FDA Registration: 3005325790
Products: Bone Cement (FDA Code: LOD), Cervical Collars, Steinman Pins, Bone Screws, Pedicle Screws, Bone Fixation Plate (FDA Code: HRS), ...
Elite Surgical Supplies (pty) Ltd is engaged in the business of arthroplasty and orthopaedic devices. Our arthoplasty products include bone cements, hips, knee, and shoulders. Our spinal product line more...
www.elitesurgical.com | Send Inquiry | Phone: +27-(12)-3860012
FDA Registration: 3005325790
Products: Bone Cement (FDA Code: LOD), Cervical Collars, Steinman Pins, Bone Screws, Pedicle Screws, Bone Fixation Plate (FDA Code: HRS), ...
Elite Surgical Supplies (pty) Ltd is engaged in the business of arthroplasty and orthopaedic devices. Our arthoplasty products include bone cements, hips, knee, and shoulders. Our spinal product line more...
Medyssey Co., Ltd. | Address: 722-3, 4f Science Tower, Jiheang-Dong, Dongucheon-City, Gyeonggi-Do, S. Korea, Dongucheon-City 722-3, Korea, Republic Of 
Phone: +82-(031)-8790414
FDA Registration: 3007485169
Products: Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Medyssey Co., Ltd. deals with spinal pedicle fixation & spondylolisthesis spinal fixation orthosis. more...
Phone: +82-(031)-8790414
FDA Registration: 3007485169
Products: Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Medyssey Co., Ltd. deals with spinal pedicle fixation & spondylolisthesis spinal fixation orthosis. more...
U&i Corp. | Address: 529-1 Yonghyun-Dong, Euijungbu, Kyunggi-Do 480-050, Korea, Republic Of
Phone: +82-(31)-852 0102
FDA Registration: 9617297
Products: Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Drill Bit (FDA Code: HTW), ...
U&i Corp. deals with benders, bending/contouring instruments, bone rasps, bone taps, compression instruments and depth gauges. We also offer socket pusher, spinal interlaminal fixation, spinal interve more...
Phone: +82-(31)-852 0102
FDA Registration: 9617297
Products: Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Drill Bit (FDA Code: HTW), ...
U&i Corp. deals with benders, bending/contouring instruments, bone rasps, bone taps, compression instruments and depth gauges. We also offer socket pusher, spinal interlaminal fixation, spinal interve more...
GS Medical Co., Ltd. | Address: 170-6 Seogeun-Ri, Paltan-Myun, Hwasung-Si, Kyungki-Do 445-914, Korea, Republic Of
Phone: +82-(2)-208-27777
FDA Registration: 3005596514
Products: Orthopedic Manual Surgical Instrument (FDA Code: LXH), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), Spinal Pedicle Fixation Orthosis For Degenerative Disc Disease (FDA Code: NKB), ...
GS Medical Co., Ltd. is engaged in the production of orthopedic manual surgical instruments and spinal fixation systems. more...
Phone: +82-(2)-208-27777
FDA Registration: 3005596514
Products: Orthopedic Manual Surgical Instrument (FDA Code: LXH), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), Spinal Pedicle Fixation Orthosis For Degenerative Disc Disease (FDA Code: NKB), ...
GS Medical Co., Ltd. is engaged in the production of orthopedic manual surgical instruments and spinal fixation systems. more...
Tae Yeon Medical Co Ltd | Address: #1642-4 Donghwa-Ri, Munmak-eup, wonju-Si Gangwon-do 220-801, Korea, Republic Of
www.tymedical.com | Phone: +82-(32)-235-7375
Products: Probes (FDA Code: HXB), Bone Taps (FDA Code: HWX), Nail Extractors (FDA Code: HWB), Wire Cutters (FDA Code: HXZ), Laser Power Probe, Laparoscopic Probes, ...
Tae Yeon Medical Co Ltd manufactures spinal systems, external fixator systems, internal fixator systems, trauma systems and surgical instruments. Our external fixation system is used for distal radius more...
www.tymedical.com | Phone: +82-(32)-235-7375
Products: Probes (FDA Code: HXB), Bone Taps (FDA Code: HWX), Nail Extractors (FDA Code: HWB), Wire Cutters (FDA Code: HXZ), Laser Power Probe, Laparoscopic Probes, ...
Tae Yeon Medical Co Ltd manufactures spinal systems, external fixator systems, internal fixator systems, trauma systems and surgical instruments. Our external fixation system is used for distal radius more...
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FDA Code / Regulation: MNH / 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:
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