FDA.reportPublic FDA data

Surgical screwdriver, reusable

Definition
A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.
GUDID devices
16,229
Last updated
2026-07-15 00:48:11

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08809918257320LW Oss Abutment Driver EngineOssvis Co., Ltd.HORSE2024-08-01
08809918257337LW Oss Abutment Driver WrenchOssvis Co., Ltd.HORSW2024-08-01
08809918273252LW Oss Abutment Driver EngineOssvis Co., Ltd.HLWORSE2024-10-25
08809918273269LW Oss Abutment Driver WrenchOssvis Co., Ltd.HLWORSW2024-10-25
10855068008423Lock ActivatorCURVAFIX, INC.CLA-0012022-06-20
00196449017348A.L.P.S. mvX™Tyber Medical, LLC770001151A2026-06-04
00196449017379A.L.P.S. mvX™Tyber Medical, LLC770001060A2026-06-04
00196449017386A.L.P.S. mvX™Tyber Medical, LLC770001080A2026-06-04
00196449017393A.L.P.S. mvX™Tyber Medical, LLC770001150A2026-06-04
00196449017454A.L.P.S. mvX™Tyber Medical, LLC770001040A2026-06-04
00196449017553A.L.P.S. mvX™Tyber Medical, LLC770900002A2026-06-04
10884521543881SigniaCovidien LPSIGMRET2017-07-24
00816127027215InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLC10-95-21322026-06-01
00816127027246InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLC10-95-20792026-06-01
00816127027253InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLC10-95-20802026-06-01
07290115932898Cannulated Screwdriver External sleevePREMIA SPINE LTD865132026-06-01
07290115935622Cannulated Screwdriver Inner Shaft ShortPREMIA SPINE LTD882642026-06-01
07290115935639Cannulated Screwdriver Handle Assy ShortPREMIA SPINE LTD882652026-06-01
07290115935646Cannulated Screwdriver External sleeve ShortPREMIA SPINE LTD882662026-06-01
07290115935653Cannulated Screwdriver Handle Assy XLPREMIA SPINE LTD872452026-06-01
07290115935660Cannulated Screwdriver Inner Shaft XLPREMIA SPINE LTD871542026-06-01
00840536822741Response 5.5/6.0ORTHOPEDIATRICS CORP.01-1300-65352026-05-30
00840536822758Response 5.5/6.0ORTHOPEDIATRICS CORP.01-1300-65362026-05-30
05712149027408Screwdriver HexaDriveOticon Medical AB2654972024-06-14
00887868561368VersaNail®Biomet Orthopedics, LLC2810-13-0372023-09-07
00083208000256Tatum Surgical-Screw DriverSuncoast Dental, IncBone Fixation Screw Latch-Grip Driver2020-11-13
00190376054674ArsenalALPHATEC SPINE, INC.877132020-06-17
00190376076621SolanasALPHATEC SPINE, INC.63961-12020-06-17
00190376139616InvictusALPHATEC SPINE, INC.161382020-06-17
00190376139623InvictusALPHATEC SPINE, INC.161442020-06-17
00190376146614KodiakALPHATEC SPINE, INC.16015-032020-06-17
00190376146621InvictusALPHATEC SPINE, INC.16015-042020-06-17
00190376146638InvictusALPHATEC SPINE, INC.16015-012020-06-17
00190376148687InvictusALPHATEC SPINE, INC.16112-012020-06-17
00190376160016AMPALPHATEC SPINE, INC.117-200-052020-06-17
00190376180298AMPALPHATEC SPINE, INC.117-1202020-06-17
00190376185811InvictusALPHATEC SPINE, INC.171382020-06-17
00190376192574InvictusALPHATEC SPINE, INC.170112020-06-17
00190376192604InvictusALPHATEC SPINE, INC.170122020-06-17
00190376192710InvictusALPHATEC SPINE, INC.171112020-06-17
00190376192802InvictusALPHATEC SPINE, INC.170102020-06-17
00190376195803KodiakALPHATEC SPINE, INC.170302020-06-17
00190376195827KodiakALPHATEC SPINE, INC.170312020-06-17
00190376195841InvictusALPHATEC SPINE, INC.171302020-06-17
00190376195865InvictusALPHATEC SPINE, INC.171312020-06-17
00190376204611InvictusALPHATEC SPINE, INC.170142020-06-17
00190376207735AMPALPHATEC SPINE, INC.117-1102020-06-17
00190376207742AMPALPHATEC SPINE, INC.117-1152020-06-17
00190376207759AMPALPHATEC SPINE, INC.117-1252020-06-17
00190376215723Trestle LuxeALPHATEC SPINE, INC.713-00122020-06-17
00190376217833InvictusALPHATEC SPINE, INC.170552020-06-17
00190376234175InvictusALPHATEC SPINE, INC.170262020-06-17
00190376234717InvictusALPHATEC SPINE, INC.170602020-06-17
00190376473000InvictusALPHATEC SPINE, INC.17950-1752023-01-05
00190376473024InvictusALPHATEC SPINE, INC.17950-2502023-01-05
00190376473048InvictusALPHATEC SPINE, INC.17951-2252023-01-05
00190376473284InvictusALPHATEC SPINE, INC.17851-1752023-01-05
00190376475196InvictusALPHATEC SPINE, INC.17851-N2023-01-05
00190376475219InvictusALPHATEC SPINE, INC.17951-N2023-01-05
00190376662220IdentiTi II ALIF SAALPHATEC SPINE, INC.834-50102026-04-15
00190376666198AscendALPHATEC SPINE, INC.160-3002025-10-21
00190376666204AscendALPHATEC SPINE, INC.160-3012025-10-21
00190376666211AscendALPHATEC SPINE, INC.160-3102025-10-21
00190376680576ProximityALPHATEC SPINE, INC.387-00372026-04-27
00190376706566InvictusALPHATEC SPINE, INC.178562026-04-09
00192629271579EVOLUTION®Microport Orthopedics Inc.E5001005CN2020-05-28
00192629271760EVOLUTION®Microport Orthopedics Inc.E5001004CN2020-05-28
00192629295230MicroportMicroport Orthopedics Inc.P3SDTOUS2021-01-14
00192629295247MicroportMicroport Orthopedics Inc.8400UD032021-01-14
00196449023363VOLT™ Wrist Treatment SystemTyber Medical, LLC03.424.3032025-10-21
00197157049591Zavation CUSTOM SCREWDRIVERZavation LLCZAV-13772024-12-10
00197157073374ZAVATION SCREWDRIVERZavation LLC989-2024-CP2025-09-16
00197157081492ZAVATION DRIVERZavation LLCZAV-14102026-05-14
00199150024452n/aMEDTRONIC SOFAMOR DANEK, INC.36500052026-03-27
00199150024476n/aMEDTRONIC SOFAMOR DANEK, INC.36062002026-04-11
00199150024889n/aMEDTRONIC SOFAMOR DANEK, INC.36501132026-03-27
00199150024926n/aMEDTRONIC SOFAMOR DANEK, INC.36562012026-03-27
00199150024933n/aMEDTRONIC SOFAMOR DANEK, INC.36522152026-03-27
00199150024940n/aMEDTRONIC SOFAMOR DANEK, INC.36500152026-03-27
00199150024957n/aMEDTRONIC SOFAMOR DANEK, INC.36520002026-03-27