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
16,436
Last updated
2026-10-29 05:55:26

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00190376632919InvictusALPHATEC SPINE, INC.19869-N2026-10-20
07290115935677XL AdaptorPREMIA SPINE LTD871462026-10-20
07290115935905XL Screwdriver CMPREMIA SPINE LTD891972026-10-20
07290115935912Screwdriver CMPREMIA SPINE LTD891732026-10-20
00199150076451Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.X36902502026-10-19
00199150080373Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.X02260452026-10-19
00199150080380Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.X02260462026-10-19
00199150080397Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.X02260472026-10-19
00886385018591STARStryker GmbH930-00292017-06-27
00886385018614STARStryker GmbH930-00322017-06-27
00886385018744STARStryker GmbH933-0001-032017-06-27
00886385018751STARStryker GmbH933-0001-042017-06-27
00886385018805STARStryker GmbH933-0002-032017-06-27
00886385019000STARStryker GmbH933-00232017-06-27
00886385019024STARStryker GmbH933-00242017-06-27
07290115932874Cannulated Screwdriver inner shaftPREMIA SPINE LTD865082026-10-18
07290115932881Cannulated Screwdriver Handle AssyPREMIA SPINE LTD865102026-10-18
M697X06402401Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.X064-02402026-10-14
08055727370785FLEX. CARDANIC SCREWDRIVER COATED HEX. 3,5 mm CONN. ZIMMERHPF SRL01.32.10.02902022-09-08
G141526051160Carnegie Surgical LLCCarnegie Surgical LLC526-051162026-10-07
00840493441696RIVA Pedicle Screw SystemXENIX MEDICAL LLCFG1-A5-0000132026-10-05
07908854001811Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDAHS00112026-09-30
09353903002529FO Micro Screw SystemFIELD ORTHOPAEDICS PTY LTDBTSC000292020-05-19
10886705013104NADEPUY MITEK, LLC2546042015-09-01
10886705013531INTRAFIXDEPUY MITEK, LLC2546712015-09-01
10888857596719Xia® 3VB Spine LLCPRO-1432-012026-05-12
10888857596726Xia® 3VB Spine LLCPRO-1432-022026-05-12
10888857596733Xia® 3VB Spine LLCPRO-1432-032026-05-12
00840096400885Viant Medical, LLCVIANT MEDICALT1054292020-05-29
00815432026012MotoBANDCROSSROADS EXTREMITY SYSTEMSMotoBAND CP, H10 Non-Retaining Driver2018-08-10
00840481138430LOCATOR, compatible with Nobel BiocareZest Anchors, LLC085362026-09-29
00810112592627TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSScrewdriver T15 for 3.0/3.5/4.0 Screws2024-02-23
00810112592818TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSScrewdriver T6 for 2.0 Screws2024-02-23
00810112592825TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSScrewdriver T8 for 2.5/3.0 Screws2024-02-23
00810112597493TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMS03.900.3632026-02-10
00810112597950MOTOBAND InstrumentsCROSSROADS EXTREMITY SYSTEMSGSOURCE H10 RETAINING DRIVER2024-08-01
00810112597967DynaForceCROSSROADS EXTREMITY SYSTEMSgSource H8 Retaining Driver2024-08-07
00810112599756TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMS03.900.4252026-02-10
00815432022687MotoBAND H10 DriverCROSSROADS EXTREMITY SYSTEMS1305152022-11-30
00815432023844DynaFORCE Utility Plate Trial Kit - 4 HoleCROSSROADS EXTREMITY SYSTEMS7000-UPTK-42022-11-30
00815432023851DynaFORCE Utility Plate Trial Kit - Z PlateCROSSROADS EXTREMITY SYSTEMS7000-UPTK-Z2022-11-30
00815432023868DynaFORCE Utility Plate Trial Kit - 5 HoleCROSSROADS EXTREMITY SYSTEMS7000-UPTK-52022-11-30
00815432023875DynaFORCE Vero Plate Trial Kit - ProximalCROSSROADS EXTREMITY SYSTEMS7000-RPTK-P2022-11-30
00815432023882DynaFORCE Vero Plate Trial Kit - DistalCROSSROADS EXTREMITY SYSTEMS7000-RPTK-D2022-11-30
00815432023899DynaFORCE Vero Plate Trial Kit - Tri JointCROSSROADS EXTREMITY SYSTEMS7000-RPTK-TJ2022-11-30
00815432028092MotoBAND CP DynaFORCE™CROSSROADS EXTREMITY SYSTEMS7000-HNDL2020-05-04
00840314246295gSourceGSOURCE LLCgS 86.44202020-03-03
00840314246349gSourceGSOURCE LLCgS 86.45302020-03-03
10886982345462VOLTSynthes GmbH03.536.1802026-09-25
07392532000683Astra Tech Implant System®Dentsply Implants Manufacturing GmbH221222022-07-01
07392532000690Astra Tech Implant System®Dentsply Implants Manufacturing GmbH221242022-07-01
07392532000997Astra Tech Implant System®Dentsply Implants Manufacturing GmbH221922022-07-14
07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbH225062022-07-14
07392532001987Astra Tech Implant System®Dentsply Implants Manufacturing GmbH225072022-07-14
07392532001994Astra Tech Implant System®Dentsply Implants Manufacturing GmbH225082022-07-14
07392532002021Astra Tech Implant System®Dentsply Implants Manufacturing GmbH225142022-07-14
07392532002038Astra Tech Implant System®Dentsply Implants Manufacturing GmbH225152022-07-14
07392532002045Astra Tech Implant System®Dentsply Implants Manufacturing GmbH225162022-07-14
07392532002069Astra Tech Implant System®Dentsply Implants Manufacturing GmbH225482022-07-14
07392532002076Astra Tech Implant System®Dentsply Implants Manufacturing GmbH225492022-07-14
07392532002397Astra Tech Implant System®Dentsply Implants Manufacturing GmbH226322022-07-14
07392532002489Astra Tech Implant System®Dentsply Implants Manufacturing GmbH226882022-07-14
07392532002496Astra Tech Implant System®Dentsply Implants Manufacturing GmbH226892022-07-14
07392532003097Astra Tech Implant System®Dentsply Implants Manufacturing GmbH228502022-07-14
07392532037313Astra Tech Implant System®Dentsply Implants Manufacturing GmbH241372022-07-14
07392532037320Astra Tech Implant System®Dentsply Implants Manufacturing GmbH241382022-07-14
07392532037337Astra Tech Implant System®Dentsply Implants Manufacturing GmbH241392022-07-14
07392532037351Astra Tech Implant System®Dentsply Implants Manufacturing GmbH240932022-07-14
07392532037368Astra Tech Implant System®Dentsply Implants Manufacturing GmbH240942022-07-14
07392532037375Astra Tech Implant System®Dentsply Implants Manufacturing GmbH240972022-07-14
07392532037382Astra Tech Implant System®Dentsply Implants Manufacturing GmbH240752022-07-14
07392532037405Astra Tech Implant System®Dentsply Implants Manufacturing GmbH240992022-07-14
07392532037412Astra Tech Implant System®Dentsply Implants Manufacturing GmbH241002022-07-14
07392532037436Astra Tech Implant System®Dentsply Implants Manufacturing GmbH241342022-07-14
07392532037443Astra Tech Implant System®Dentsply Implants Manufacturing GmbH241352022-07-14
07392532037542Astra Tech Implant System®Dentsply Implants Manufacturing GmbH240952022-07-14
07392532037559Astra Tech Implant System®Dentsply Implants Manufacturing GmbH240962022-07-14
07392532063077Astra Tech Implant System®Dentsply Implants Manufacturing GmbH224342022-07-14
07392532063114Astra Tech Implant System®Dentsply Implants Manufacturing GmbH224372022-07-14
07392532066412Astra Tech Implant System®Dentsply Implants Manufacturing GmbH243572022-07-14