FDA.reportPublic FDA data

Bone awl, single-use

Definition
A spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a single-use device.
GUDID devices
31
Last updated
2025-09-25 19:38:11

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
03662674000495PediGuard DSG ConnectSPINEGUARDPediGuard DSG Connect Ø2.52025-09-17
03662674000501PediGuard DSG ConnectSPINEGUARDPediGuard DSG Connect Curv2025-09-17
03662674000518PediGuard DSG ConnectSPINEGUARDPediGuard DSG Connect Ø2.5 XS2025-09-17
03662674000525PediGuard DSG ConnectSPINEGUARDPediGuard DSG Connect Curv XS2025-09-17
03662674000471PediGuard DSG ConnectSPINEGUARDPediGuard DSG Connect Ø4.02025-08-28
03662674000488PediGuard DSG ConnectSPINEGUARDPediGuard DSG Connect Ø3.22025-08-28
00810056991975aprevo®Carlsmed, Inc.13702025-06-23
00810056991999aprevo®Carlsmed, Inc.13802025-06-23
00810056993009aprevo®Carlsmed, Inc.15102025-06-23
00810056993023aprevo®Carlsmed, Inc.15302025-06-23
B648C1155400150Acumen Thoracolumbar Plate SystemCURITEVA, INC.C1155-400-152025-02-21
08800298539297Surgical InstrumentOSTEONIC CO.,Ltd.475AD2025-02-06
B648C11554100Acumen Thoracolumbar Plate SystemCURITEVA, INC.C1155-4102024-10-31
00190376543406InvictusALPHATEC SPINE, INC.17884-022024-09-03
00190376544335InvictusALPHATEC SPINE, INC.17884-012024-09-03
B648C10554000Prowess Laminoplasty SystemCURITEVA, INC.C1055-4002024-01-05
B648C10554100Prowess Laminoplasty SystemCURITEVA, INC.C1055-4102024-01-05
B648C5051000Prodigy Pedicle Screw SystemCURITEVA, INC.C505-1002024-01-04
B648C5051100Prodigy Pedicle Screw SystemCURITEVA, INC.C505-1102024-01-04
B648C1554000Aptitude Anterior Cervical Plate SystemCURITEVA, INC.C155-4002024-01-03
B648C1554100Aptitude Anterior Cervical Plate SystemCURITEVA, INC.C155-4102024-01-03
B90839940556313Isto Disposable Awl 5.5/6.0 AnchorMainstream Medical Devices, LLC399-40-556-3132023-07-17
B90839940657312Isto Disposable Awl 6.5/7.0 AnchorMainstream Medical Devices, LLC399-40-657-3122023-07-17
B90839940758311Isto Disposable Awl 7.5/8.0 AnchorMainstream Medical Devices, LLC399-40-758-3112023-07-17
B90839940859310Isto Disposable Awl 8.5/9.0 AnchorMainstream Medical Devices, LLC399-40-859-3102023-07-17
00888867380110Arthrex®ARTHREX, INC.AR-1091CP-100-12022-07-25
00888867380134Arthrex®ARTHREX, INC.AR-1091CP-70-12022-07-25
10888867380100Arthrex®ARTHREX, INC.AR-1091CP-1002022-07-25
10888867380124Arthrex®ARTHREX, INC.AR-1091CP-702022-07-25