FDA.reportPublic FDA data

Surgical screwdriver, single-use, sterile

Definition
A sterile, non-powered tool that fits into a screw head in order to apply rotation to tighten/loosen/remove a screw during a surgical procedure. It typically has a high-grade stainless steel shaft with a distal end dedicated to fit into a screw head that may be slotted, Phillips (cross head), Pozidriv (Supadriv), Torx, Hex (Allen), Robertson (square), spanner head (twin pins), Polydrive, or one-way (clutch). The proximal end of the shaft may have a handle for manual use, or it may have a profiled tang that fits into an interchangeable screwdriver handle, a manually-operated chuck, or a power driver. This is a single-use device.
GUDID devices
64
Last updated
2022-08-11 09:17:41

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00889797056700MICAWRIGHT MEDICAL TECHNOLOGY, INC.57S020202018-01-29
00889797056717MICAWRIGHT MEDICAL TECHNOLOGY, INC.57S020252018-01-29
00850038154189DynaBunionCROSSROADS EXTREMITY SYSTEMS1500-48012022-08-02
10886982261656NASynthes GmbH03.111.117S2017-03-14
H98103617971S0NASynthes GmbH03.617.971S2015-09-14
00887868470950Trauma Fixation SystemsBiomet Orthopedics, LLC14-4420842022-01-07
00817701029205Nextra PEEK Hammertoe Correction SystemMedartis Inc.PHSTRD2021-11-24
00817701029212Nextra PEEK Hammertoe Correction SystemMedartis Inc.PHANGD2021-11-24
D86349440SherlockOpen Implants, LLC49442021-02-18
D86353280SherlockOpen Implants, LLC53282021-02-18
09008737527907Medical Screwdriver (SD 2)Med-El Elektromedizinische Geräte Gesellschaft m.b.H.527902021-02-09
00815432028733MotoBANDCROSSROADS EXTREMITY SYSTEMSDynaBunion Instrument Kit2021-01-06
00815432028948MotoBANDCROSSROADS EXTREMITY SYSTEMSDynaBunion Sharps Kit2021-01-06
00815432028955MotoBANDCROSSROADS EXTREMITY SYSTEMSDynaBunion Re-Cut Instrument Kit2020-12-30
00815432028740MotoBANDCROSSROADS EXTREMITY SYSTEMSAnti-Drift Bolt Instrument Kit2020-12-16
B471200199150EPS Plating SystemGRAMERCY EXTREMITY ORTHOPEDICS LLC200199152020-10-23
00817701026976InCore TMT Medartis Inc.IC-TMT-T82020-05-08
00889024464094FastFrame™Zimmer, Inc.47-5300-050-012017-09-13
00889024464100FastFrame™Zimmer, Inc.47-5300-010-012017-09-13
00889024508576FastFrame™Zimmer, Inc.00-5300-050-012018-09-14
00889024561977FastFrame™Zimmer, Inc.00-5300-050-012018-11-14
008878680947983.5MM HEX SCREW EXTRACTORBiomet Orthopedics, LLC14-4420842017-07-28
00887868094897RECON SCREW EXTRACTORBiomet Orthopedics, LLC14-4420992017-07-28
00887868129773TSP HIP FX PLATING SYSTEM7.5MM LAG SCREW REMOVAL TOOLBiomet Orthopedics, LLC14-4515682016-09-26
00887868129780TSP HIP FX PLATING SYSTEMSCREW EXTRACTOR, 4.5MM SCREWBiomet Orthopedics, LLC14-4515672016-09-26
00888118096593LEVEL ONE, STERILEKLS-Martin L.P.50-991-15-712018-09-27
00888118096616LEVEL ONE, STERILEKLS-Martin L.P.50-991-20-712018-09-27
00888118096630LEVEL ONE, STERILEKLS-Martin L.P.50-993-15-712018-09-24
00888118096654LEVEL ONE, STERILEKLS-Martin L.P.50-993-20-712018-09-27
00887868027888VERSANAIL®Biomet Orthopedics, LLC2810-01-1192017-07-28
00840118108928Olive Wire Kit, SmallFLOWER ORTHOPEDICS CORPORATIONOWK 0012016-12-08
00817701021414InCore LapidusMedartis Inc.IC-LAP-T102019-02-05
00817701027041InCore LapidusMedartis Inc.IC-LAP-TH202019-11-21
00815432027798MotoBANDCROSSROADS EXTREMITY SYSTEMSH10 Self Retaining Driver2019-08-21
08052990971862Orthopaedic Surgical InstrumentsCITIEFFE SRLT-wrench, 6mm2020-03-26
00817701026518Stratum Foot Plating SystemMedartis Inc.TLH-202019-11-18
00840118115100Removal Driver, T6FLOWER ORTHOPEDICS CORPORATIONRMD 1002019-06-14
00840118115117Removal Driver, T15FLOWER ORTHOPEDICS CORPORATIONRMD 2002019-06-14
00840118115124Removal Driver, T25FLOWER ORTHOPEDICS CORPORATIONRMD 3002019-06-14
00810012485777DRIVER 1.0MM STAR AOBIOPRO, INC.222992019-06-12
00810012485166HEX DRIVER 3.0 3.5BIOPRO, INC.183242019-06-06
00810012485173HEX DRIVER 4.0 4.5BIOPRO, INC.183252019-06-06
00810012485234HEX DRIVER 2.0 2.5BIOPRO, INC.183232019-06-06
00810012485258HEX DRIVER 6.5BIOPRO, INC.197512019-06-06
B471200099080GEO Bone Screw SystemGRAMERCY EXTREMITY ORTHOPEDICS LLC200099082018-10-10
B471200099100GEO Bone Screw SystemGRAMERCY EXTREMITY ORTHOPEDICS LLC200099102018-10-10
B471200099200GEO Bone Screw SystemGRAMERCY EXTREMITY ORTHOPEDICS LLC200099202018-10-10
B471201099200GEO Bone Screw SystemGRAMERCY EXTREMITY ORTHOPEDICS LLC201099202018-10-10
B471201099300GEO Bone Screw SystemGRAMERCY EXTREMITY ORTHOPEDICS LLC201099302018-10-10
08051739535006Orthopaedic Surgical InstrumentsCITIEFFE SRLT-wrench, 6mm2019-03-21
00848665010916ACTIVATION TOOL ADVANCED ORTHOPAEDIC SOLUTIONS, INC.S04572016-03-07
00850310006410CrossRoads™ Bone ScrewCROSSROADS EXTREMITY SYSTEMSSnap-Off Driver - Sterile2018-07-11
00850310006861CrossRoads Screw SystemCROSSROADS EXTREMITY SYSTEMS4.0 Headed Implant Prep Kit Including Reamer2016-03-07
00880304535893DVR® CROSSLOCK EPAK™SCREW DRIVERBiomet Orthopedics, LLC2120000022017-04-18
00885556119303NASmith & Nephew, Inc.710703492015-08-25
00885556119310NASmith & Nephew, Inc.710703482015-08-25
00885556119327NASmith & Nephew, Inc.710703472015-08-25
00885556119334NASmith & Nephew, Inc.710703462015-08-25
00885556119341NASmith & Nephew, Inc.710703452015-08-25
00817701020837Nextra Hammertoe Correction SystemMedartis Inc.NX-DR2017-06-12
00817701020844Re+Line Bunion Correction SystemMedartis Inc.RS-DR2017-06-12
00817701020851MSP Metatarsal Shortening Plate DriverMedartis Inc.MS-DR2017-06-12
00817701021339MSP Metatarsal Shortening Plate Torque Limited DriverMedartis Inc.MS-DRTL2018-01-24
00815432023271CrossRoads™ Bone ScrewCROSSROADS EXTREMITY SYSTEMSSnap-Off Screw Driver - One Piece2017-01-03