FDA.reportPublic FDA data

Internal spinal fixation procedure kit, single-use

Definition
A collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a single-use device.
GUDID devices
1,429
Last updated
2026-06-16 06:05:39

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810017915354Saber-C, Spike Driver 5-7, MedialELEVATION SPINE, INC.CI-DRIVER3M-5-72026-06-05
00810017915361Saber-C, Spike Driver 5-7, LateralELEVATION SPINE, INC.CI-DRIVER3L-5-72026-06-05
00810017915378Saber-C, Spike Driver 8-9, MedialELEVATION SPINE, INC.CI-DRIVER3M-8-92026-06-05
00810017915385Saber-C, Spike Driver 8-9, LateralELEVATION SPINE, INC.CI-DRIVER3L-8-92026-06-05
04052536162086neon³ CT spinal stabilizationUlrich GmbH & Co. KGCS 3962-012016-09-22
00852776006089DTRAX® Spinal SystemProvidence Medical Technology, Inc.DX-22-1002017-06-27
00852776006188DTRAX® Spinal System-LProvidence Medical Technology, Inc.DX-22-6002016-10-12
00852776006508CORUS Spinal System-XProvidence Medical Technology, Inc.DX-22-3002020-06-12
00852776006690CORUS NAVIGATION ACCESS SYSTEM-GLX Providence Medical Technology, Inc.DX-01-1802025-11-03
07640177820150Neo Medical Pedicle Screw SystemNeo Medical SASI-00-00-002023-01-25
07640177820389Neo Medical Pedicle Screw SystemNeo Medical SACD-00-00-002023-01-25
07640177820402Neo Medical Pedicle Screw SystemNeo Medical SARE-00-00-002023-01-25
07640177822000Neo Medical Cage kitNeo Medical SACI-00-00-002023-01-19
07640177822239Neo Medical Cage kitNeo Medical SACI-00-TL-002023-01-26
00810056991302aprevoCarlsmed, Inc.10802023-01-09
00810017915262Screw HandleELEVATION SPINE, INC.CI-HANDLE-SR2025-09-12
10888857415928Brainlab Compatible K2M Navigation InstrumentsVB Spine LLC7601-N90011-B2025-09-09
10888857434479NIAGARA® Lateral Access SystemVB Spine LLCAC01-900632020-06-10
10888857514737OZARK Cervical Plate SystemVB Spine LLCSP-4174-012020-11-09
10888857514744OZARK Cervical Plate SystemVB Spine LLCSP-4174-022020-11-09
10888857514751OZARK Cervical Plate SystemVB Spine LLCSP-4174-032020-11-09
10888857514768OZARK Cervical Plate SystemVB Spine LLCSP-4174-042020-11-09
00852776006546CORUS-LX LevelOne, 4mmProvidence Medical Technology, Inc.DX-50-4092025-08-13
00195377026309MaXcessNuvasive, Inc.39000102020-11-10
00887517061072MaXcessNuvasive, Inc.39000152020-11-10
07640387660843GoLIF! Lumbar Interbody Fusion SystemGetSet Surgical SA40200012025-04-01
07640387660850GoLIF! Lumbar Interbody Fusion SystemGetSet Surgical SA40200022025-04-01
00810017914876Strike HubELEVATION SPINE, INC.522-810022025-03-28
00852776006683CORUS PCSS LevelOne, 4mmProvidence Medical Technology, Inc.DX-50-4052025-02-19
00852776006584CORUS Spinal System-LXProvidence Medical Technology, Inc.DX-22-5002024-11-13
00852776006638CORUS Navigation Access SystemProvidence Medical Technology, Inc.DX-01-1602024-11-13
M9433500010000Minuteman Spinal Simplicity, LLC35-0001-0002023-08-09
07640177821072Neo Medical Pedicle Screw SystemNeo Medical SASI-RE-SE-002023-01-26
00195377159847XLIFNuvasive, Inc.3250020P2024-04-23
00195377159854XLIFNuvasive, Inc.3250030P2024-04-23
10888857551466NAPA Access SystemVB Spine LLC8030-901862024-01-04
10888857551473NAPA Access SystemVB Spine LLC8030-901872024-01-04
10888857551480NAPA Access SystemVB Spine LLC8030-901882024-01-04
10888857551497NAPA Access SystemVB Spine LLC8030-901892024-01-04
10888857551503NAPA Access SystemVB Spine LLC8030-901902024-01-04
10888857551510NAPA Access SystemVB Spine LLC8030-901912024-01-04
10888857551527NAPA Access SystemVB Spine LLC8030-901922024-01-04
10888857551534NAPA Access SystemVB Spine LLC8030-901932024-01-04
10888857551541NAPA Access SystemVB Spine LLC8030-901942024-01-04
10888857551558NAPA Access SystemVB Spine LLC8030-901952024-01-04
10888857551565NAPA Access SystemVB Spine LLC8030-901962024-01-04
10888857551572NAPA Access SystemVB Spine LLC8030-901972024-01-04
10888857551589NAPA Access SystemVB Spine LLC8030-901982024-01-04
10888857551596NAPA Access SystemVB Spine LLC8030-901992024-01-04
10888857551602NAPA Access SystemVB Spine LLC8030-902002024-01-04
10888857551619NAPA Access SystemVB Spine LLC8030-902012024-01-04
10888857551626NAPA Access SystemVB Spine LLC8030-902022024-01-04
00840019970655Reform MC Screw SystemPRECISION SPINE, INC.59-SP-07202023-11-17
17640177821260Neo Medical Pedicle screw kitNeo Medical SASI-GR-SG-002023-10-11
M943350001000Minuteman Spinal Simplicity, LLC35-0001-0002023-08-09
00840097506333restor3d Disposable Instrument KitRestor3d, Inc.4110-S0012023-02-10
00840097507460restor3d Disposable InstrumentRestor3d, Inc.4110-S0142023-02-10
00840097507477restor3d Disposable InstrumentRestor3d, Inc.4110-S0242023-02-10
10888857000520DENALI MI Spinal SystemVB Spine LLC1001-900622022-10-17
10888857000896DENALI MI Spinal SystemVB Spine LLC1001-901102022-10-17
10888857000919DENALI MI Spinal SystemVB Spine LLC1001-901122022-10-17
10888857185494DENALI MI Spinal SystemVB Spine LLCK2-10-2239-012022-10-17
10888857000308DENALI MI Spinal SystemVB Spine LLC1001-900312022-08-09
10888857000391DENALI MI Spinal SystemVB Spine LLC1001-900482022-08-09
10888857000643DENALI MI Spinal SystemVB Spine LLC1001-900782022-08-09
10888857001091DENALI MI Spinal SystemVB Spine LLC1001-901302022-08-09
10888857104075EVEREST Spinal SystemVB Spine LLC5101-900212022-08-09
10888857104228EVEREST Spinal SystemVB Spine LLC5101-900452022-08-09
10888857104235EVEREST Spinal SystemVB Spine LLC5101-900462022-08-09
10888857104280EVEREST Spinal SystemVB Spine LLC5101-900512022-08-09
10888857157729EVEREST Spinal SystemVB Spine LLC5101-901002022-08-09
10888857183056EVEREST Spinal SystemVB Spine LLC5001-900072022-08-09
10888857183070EVEREST Spinal SystemVB Spine LLC5001-900092022-08-09
10888857216570EVEREST Spinal SystemVB Spine LLC5101-901492022-08-09
10888857230514CASPIAN Spinal SystemVB Spine LLCK2-11-2129-022022-08-09
10888857230521CASPIAN Spinal SystemVB Spine LLCK2-11-2129-032022-08-09
10888857283442EVEREST Spinal SystemVB Spine LLC5101-901922022-08-09
10888857302723EVEREST Spinal SystemVB Spine LLC5101-901752022-08-09
10888857016620CASPIAN Spinal SystemVB Spine LLC1101-900052022-08-08
10888857016637CASPIAN Spinal SystemVB Spine LLC1101-900062022-08-08