FDA.reportPublic FDA data

Orthopaedic intraoperative positioning pin, single-use

Definition
A nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a single-use device.
GUDID devices
523
Last updated
2026-10-04 01:35:57

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10888857035126RAVINE® Lateral Access SystemVB Spine LLC2701-900292022-02-14
10888857035133RAVINE® Lateral Access SystemVB Spine LLC2701-900302022-02-14
10888857035140RAVINE® Lateral Access SystemVB Spine LLC2701-900312022-02-14
10888857035157RAVINE® Lateral Access SystemVB Spine LLC2701-900322022-02-14
10888857035164RAVINE® Lateral Access SystemVB Spine LLC2701-900332022-02-14
10888857035171RAVINE® Lateral Access SystemVB Spine LLC2701-900342022-02-14
10888857035188RAVINE® Lateral Access SystemVB Spine LLC2701-900352022-02-14
10888857035195RAVINE® Lateral Access SystemVB Spine LLC2701-900362022-02-14
10888857035201RAVINE® Lateral Access SystemVB Spine LLC2701-900372022-02-14
10888857035775RAVINE® Lateral Access SystemVB Spine LLC2701-900952022-02-14
10888857035782RAVINE® Lateral Access SystemVB Spine LLC2701-900962022-02-14
10888857035799RAVINE® Lateral Access SystemVB Spine LLC2701-900972022-02-14
10888857035805RAVINE® Lateral Access SystemVB Spine LLC2701-900982022-02-14
10888857035898RAVINE® Lateral Access SystemVB Spine LLC2701-901102022-02-14
10888857404489OZARK Cervical Plate SystemVB Spine LLC8801-900752022-05-31
10888857404496OZARK Cervical Plate SystemVB Spine LLC8801-900782022-05-31
10888857427419RAVINE™ Access SystemVB Spine LLC2701-902402020-04-16
10888857427433RAVINE™ Access SystemVB Spine LLC2701-902422020-04-16
10888857427457RAVINE™ Access SystemVB Spine LLC2701-902442020-04-16
00850083430108SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.500-1062026-08-17
00850083430122SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.500-1072026-08-17
00850083430139SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.500-1082026-08-17
00193982278670N/AGLOBUS MEDICAL, INC.693.060S2026-08-14
07613327602340NAStryker Leibinger GmbH & Co. KG47610072026-07-17
05055662968545OrthoSolutions 'System26' Bone ScrewsORTHO SOLUTIONS HOLDINGS LIMITEDOS900106-NS2026-06-24
09120125220297Shark Screw® Pinsurgebright GmbHUSCP3516C2026-01-08
09120125220303Shark Screw® Pinsurgebright GmbHUSCP5018S2026-01-08
09120125220310Shark Screw® Guidewiresurgebright GmbHUSCGW122026-01-09
00810111227292K-WireTreace Medical Concepts, Inc.02-005432026-06-02
00810111224826K-WireTreace Medical Concepts, Inc.SN332025-09-10
00810111225182Drill TackTreace Medical Concepts, Inc.02-003722025-10-01
00810111227155K-WireTreace Medical Concepts, Inc.02-004722026-03-31
00810111227261K-WireTreace Medical Concepts, Inc.02-005202026-04-27
00810111227278K-WireTreace Medical Concepts, Inc.02-005222026-03-30
00810130203406MSIModern Surgical Instruments LLC96-0156S2024-01-09
00810190980774Eleganz Fusion Screw SystemDev4DI-20402025-10-01
00810190981566Eleganz IM Threaded NailDev4MI-20402026-04-23
00810190981573Eleganz IM Threaded NailDev4MI-35402026-04-23
00885556014523NASmith & Nephew, Inc.711110002015-08-29
00885556076323CHSSmith & Nephew, Inc.9122192015-08-30
00885556631270D-RADSmith & Nephew, Inc.711610142016-10-13
00888118132529LEVEL ONE EXTREMITYKLS-Martin L.P.26-627-12-912026-04-23
00888118132642LEVEL ONE SMALL BONEKLS-Martin L.P.26-850-99-912026-04-23
00888118132789LEVEL ONE SMALL BONEKLS-Martin L.P.26-875-99-912026-04-23
00888867348288Arthrex®ARTHREX, INC.AR-8941KDN-S2020-06-19
00888867348295Arthrex®ARTHREX, INC.AR-8737-39KDN-S2020-06-19
00888867348301Arthrex®ARTHREX, INC.AR-8737-39KN-S2020-06-19
00888867348318Arthrex®ARTHREX, INC.AR-8737-41KDN-S2020-06-19
00888867348325Arthrex®ARTHREX, INC.AR-8737-41KN-S2020-06-19
00888867348332Arthrex®ARTHREX, INC.AR-8750KDN-S2020-06-19
00888867348349Arthrex®ARTHREX, INC.AR-8750KN-S2020-06-19
00888867348356Arthrex®ARTHREX, INC.AR-8770KDN-S2020-06-19
00888867348363Arthrex®ARTHREX, INC.AR-8770KN-S2020-06-19
00888867348370Arthrex®ARTHREX, INC.AR-8933KDN-S2020-06-19
00888867348387Arthrex®ARTHREX, INC.AR-8933KN-S2020-06-19
00888867348394Arthrex®ARTHREX, INC.AR-8941KN-S2020-06-19
00888867348400Arthrex®ARTHREX, INC.AR-8945KDN-2S2020-06-19
00888867348417Arthrex®ARTHREX, INC.AR-8945KDN-S2020-06-19
00888867348424Arthrex®ARTHREX, INC.AR-8945KN-2S2020-06-19
00889024467828Trinica ALP Anterior Lumbar Plate SystemHighridge Medical, LLC07.01090.0012026-01-12
00889024467835Trinica ALP Anterior Lumbar Plate SystemHighridge Medical, LLC07.01311.0012026-01-12
03596010036476CHSSmith & Nephew, Inc.1108992015-08-29
03596010082565NASmith & Nephew, Inc.1280472015-08-29
03596010083241CHSSmith & Nephew, Inc.1281902015-08-29
03596010083272CHSSmith & Nephew, Inc.1281952015-08-29
03596010083289CHSSmith & Nephew, Inc.1281962015-08-29
03596010173263LARGE CANNULATED SCREWSSmith & Nephew, Inc.711105002017-11-13
03596010179685Peri-LocSmith & Nephew, Inc.711610122015-08-29
03596010179708Peri-LocSmith & Nephew, Inc.711610162015-08-29
03596010179715Peri-LocSmith & Nephew, Inc.711610202015-08-29
03596010185730GENESISSmith & Nephew, Inc.712100022015-08-29
03596010185747GENESISSmith & Nephew, Inc.712100032015-08-29
03596010298126Cannulated ScrewsSmith & Nephew, Inc.711104002015-09-28
03700586902350AUTOFIXStryker GmbH451-00312015-09-24
03700586903463AUTOFIXStryker GmbH451-11362015-09-24
07630037864523APTUSMedartis AGA-5045.44/2S2025-04-08
07630037864547APTUSMedartis AGA-5045.45/2S2025-04-08
07630037864561APTUSMedartis AGA-5045.46/2S2025-04-08
07630037864585APTUSMedartis AGA-5045.47/2S2025-04-08
09421038410363Smooth Pin - 3.2mm x 70mm – x2ENZTEC LIMITED5000-2001-22025-10-03