FDA.report

Spinal bone set screw

Definition
A small, implantable, non-bioabsorbable disc, threaded on its outside surface, intended to be threaded into the internal proximal end of a spinal bone screw head/rod adaptor, anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy).
GUDID devices
36
Last updated
2026-03-19 21:56:43

Related Product Codes

CodeDeviceSpecialtyClassDevices
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic212
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic26
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic25
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic24
NKGPosterior Cervical Screw SystemOrthopedic24
MNIOrthosis, Spinal Pedicle FixationOrthopedic23
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic21
NQWOrthosis, Spine, Plate, Laminoplasty, MetalOrthopedic21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00840283401404VyLink™VY SPINE LLC04-SS-4585-TI-N2026-03-11
00850062071001A8 INTEGR8® Porous Pedicle Screw SystemALLUMIN8, INC.A8-00-CAP2026-02-27
00850080774335A8 INTEGR8® Porous Pedicle Screw SystemALLUMIN8, INC.A8-27-CAP2026-02-27
10840642177008Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.11-87442026-01-15
10840642177794Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.11-87492026-01-15
03662663146524Gallery Laminoplasty Fixation SystemHighridge Medical, LLC14-5231042026-01-13
10840642173086Annex® 2 Adjacent Level SystemSpine Wave, Inc.11-58132026-01-09
10840642173093Annex® 2 Adjacent Level SystemSpine Wave, Inc.11-58162026-01-09
10840642177121Annex® 2 Adjacent Level SystemSpine Wave, Inc.11-58152026-01-09
088000333579334CIS SOLAR SPINE SYSTEMALPHANOX CO.,LTD.4222-00012015-09-24
088000333580534CIS APOLLON SPINE SYSTEMALPHANOX CO.,LTD.4232-08552015-09-24
088000333580604CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.4242-00032016-08-12
088000333820274CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.4242-00042015-09-24
088000333820344CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.4242-00052016-08-12
088000333580464CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.4242-00012015-09-24
03662663239240Alta ACDF SystemHighridge Medical, LLC8405-10002025-12-18
03662663239257Alta ACDF SystemHighridge Medical, LLC8405-12022025-12-18
03662663239264Alta ACDF SystemHighridge Medical, LLC8405-12032025-12-18
03662663239271Alta ACDF SystemHighridge Medical, LLC8405-12042025-12-18
03662663239288Alta ACDF SystemHighridge Medical, LLC8405-12052025-12-18
03662663197052Aspen MIS Fusion SystemHighridge Medical, LLC6201-0001-0022025-12-17
03662663193085PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLC3301-12025-12-15
03662663194846Epic Anterior Thoracolumbar Plate SystemHighridge Medical, LLC5005-00022025-12-15
03662663112758Virage OCT Spinal Fixation SystemHighridge Medical, LLC07.01728.0012025-12-03
03662663117265Vital Spinal Fixation SystemHighridge Medical, LLC07.02010.0012025-12-03
03662663117272Vital Spinal Fixation SystemHighridge Medical, LLC07.02011.0012025-12-03
03662663128902Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLC1200-00302025-12-03
03662663153881Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLC14-5251102025-12-03
03662663147194Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLC14-5240382025-11-20
03662663147200Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLC14-524038E2025-11-20
07640450866066PERLA ®SpineArt SACPF-SC 00 02-S2025-11-20
10889981332969VirataSeaspine Orthopedics CorporationTL1-000000002025-09-26
00840493415802RIVA Posterior Fixation SystemXENIX MEDICAL LLCFG1-10-0000202025-09-15
00810055525935Granite Point Lock Set ScrewSi-Bone Inc.5031752025-08-25
00840493413624RIVA Posterior Fixation SystemXENIX MEDICAL LLCFG1-10-0000152025-08-15
00814386029865Momentum Ulrich Medical Usa, Inc.UU051-71-2001 2025-07-11