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
16,291
Last updated
2026-08-03 17:34:00

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00824846003199Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.X55981452026-07-26
00824846003205Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.X55981462026-07-26
10887587078557NASynthes GmbHSD03.503.0672026-07-24
10887587078564NASynthes GmbHSD03.503.0722026-07-24
00811714036564ThunderboltRESPONSIVE ORTHOPEDICS LLC2859682025-05-14
04546540258991NAStryker Leibinger GmbH & Co. KG62-174012016-10-19
07613153171393NAStryker Leibinger GmbH & Co. KG92-121802016-10-19
07613327369489AXSStryker Leibinger GmbH & Co. KG62-121782019-09-11
08800076417946Removal DriverTruabutment Korea Co.,LtdRDR16S2025-12-11
08800076417953Removal DriverTruabutment Korea Co.,LtdRDR16L2025-12-11
08800076417960Removal DriverTruabutment Korea Co.,LtdRDR20S2026-03-19
08800076417977Removal DriverTruabutment Korea Co.,LtdRDR20L2025-12-11
00888118154712LEVEL ONEKLS-Martin L.P.50-994-15-072026-07-21
04546540366818NAStryker Leibinger GmbH & Co. KG62-920232016-10-19
04546540558695NAStryker Leibinger GmbH & Co. KG62-202332016-10-19
07613154029891NAStryker Leibinger GmbH & Co. KG92-201402016-10-19
07613154731664NAStryker Leibinger GmbH & Co. KG92-621402016-10-19
07613327090123NAStryker Leibinger GmbH & Co. KG62-201492016-10-19
07613327090192NAStryker Leibinger GmbH & Co. KG62-201392016-10-19
08800070234877Bite Impression Coping DriverIzenimplant Co., Ltd.BICD4018L2024-09-13
08800070234945Bite Impression Coping DriverIzenimplant Co., Ltd.BICD4014S2024-09-13
08800070235003Bite Impression Coping DriverIzenimplant Co., Ltd.BICD5018L2024-09-13
08800070235065Bite Impression Coping DriverIzenimplant Co., Ltd.BICD5014S2024-09-13
00199150081875Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.X04260032026-07-19
00763000913267Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.55961152026-07-17
07613327602272NAStryker Leibinger GmbH & Co. KG47600732026-07-17
07613327602364NAStryker Leibinger GmbH & Co. KG47600432026-07-17
07613327663501NAStryker Leibinger GmbH & Co. KG47600422026-07-17
07613327663587NAStryker Leibinger GmbH & Co. KG47600722026-07-17
08800104058714CASSIOPEIA Cervical Plate SystemGS Medical Co., Ltd.GS142-52102025-03-17
08806162199178Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.GS110-11302025-03-17
08806395499618Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.GS110-40012025-03-17
08809695589973PYXIS 3D Titanium Cervical Cage, CloseGS Medical Co., Ltd.GS110-09812026-01-28
08809695602139Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.GS110-24182025-03-17
08809885749996Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.GS110-23292025-03-17
B8034500040ORTHOMEDORTHO-MED, INC.OM 45-00042026-07-14
B8034709510ORTHOMEDORTHO-MED, INC.OM 47-09512026-07-14
B8034709530ORTHOMEDORTHO-MED, INC.OM 47-09532026-07-14
B8034709540ORTHOMEDORTHO-MED, INC.OM 47-09542026-07-14
B8034709560ORTHOMEDORTHO-MED, INC.OM 47-09562026-07-14
B8034709580ORTHOMEDORTHO-MED, INC.OM 47-09582026-07-14
B8034709610ORTHOMEDORTHO-MED, INC.OM 47-09612026-07-14
B8034803480ORTHOMEDORTHO-MED, INC.OM 48-03482026-07-14
B8034803490ORTHOMEDORTHO-MED, INC.OM 48-03492026-07-14
B8034803500ORTHOMEDORTHO-MED, INC.OM 48-03502026-07-14
B8034803520ORTHOMEDORTHO-MED, INC.OM 48-03522026-07-14
B8034803530ORTHOMEDORTHO-MED, INC.OM 48-03532026-07-14
B8034803540ORTHOMEDORTHO-MED, INC.OM 48-03542026-07-14
B8034803550ORTHOMEDORTHO-MED, INC.OM 48-03552026-07-14
B8034803560ORTHOMEDORTHO-MED, INC.OM 48-03562026-07-14
B8034803580ORTHOMEDORTHO-MED, INC.OM 48-03582026-07-14
B8034803600ORTHOMEDORTHO-MED, INC.OM 48-03602026-07-14
B8034803620ORTHOMEDORTHO-MED, INC.OM 48-03622026-07-14
08800104097959Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.GS120-23002025-03-17
08800104097973Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.GS120-30002025-03-17
08800104099731Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.GS120-24002025-03-17
08800104099847Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.GS120-09502025-03-17
08800322708224Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.GS120-23402026-04-21
08800322758175Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.GS120-89002026-04-21
08800322758267Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.GS120-89502026-04-21
08800322758274Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.GS120-89302026-04-21
08806162109436AnyPlus®GS Medical Co., Ltd.GS136-24002026-01-28
08809695639999Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.GS120-06002025-03-17
08809885715441Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.GS120-23102025-03-17
08809885717384Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.GS120-24102025-03-17
08809885799779Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.GS120-09002025-03-17
10705034712802NASynthes GmbH03.606.0112016-12-31
10705034718040NASYNTHES (U.S.A.) LP03.620.2192018-10-29
10705034768939NASynthes GmbH314.0642016-12-31
10705034768960Click'XSynthes GmbH314.0672016-12-31
10705034772608NASynthes GmbH388.3642016-12-31
D762DSA0300000Implant-OneImplant Logistics, Inc.DSA-0300-002022-06-30
D762DSA0400000Implant-OneImplant Logistics, Inc.DSA-0400-002022-06-30
D762DSA0500000Implant-OneImplant Logistics, Inc.DSA-0500-002022-06-30
00842188132513Tools - ScrewsTrimed, INC.DVTX-8/085 AO NP2026-07-09
00842188132520Tools - ScrewsTrimed, INC.DVTX-8/095 AO NP2026-07-09
04546540136831NAStryker Leibinger GmbH & Co. KG01-080572016-10-19
04719879398045Tandry Orthopedic Manual Surgical InstrumentMICROWARE PRECISION CO., LTD.303012A-K002025-05-07
04719879398052Tandry Orthopedic Manual Surgical InstrumentMICROWARE PRECISION CO., LTD.303012B-K002025-08-22
04719879398069Tandry Orthopedic Manual Surgical InstrumentMICROWARE PRECISION CO., LTD.303013A-Z002025-08-22