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Driver, Surgical, Pin
FDA product code GFC · Class 1 · General, Plastic Surgery
153
Registered devices
101
Adverse events
2
Recalls
2
510(k) clearances
Devices with this code
APEX Knee System — Omni Life Science, Inc.PediNail Intramedullary Platform — ORTHOPEDIATRICS CORP.NA — aap Implantate AGConsensus Knee System/Revision Knee System — Shalby Advanced Technologies, Inc.Consensus Knee System/Revision Knee System — Shalby Advanced Technologies, Inc.Butrex Buttress Plating System — Xtant Medical Holdings, Inc.Tahoe Unicompartmental Knee System — Shalby Advanced Technologies, Inc.VICKERS K-WIRE PIN BENDER — SONTEC INSTRUMENTS, INC.NA — aap Implantate AGPower Torque Instrumentation — ORTHOPEDIATRICS CORP.CASSIOPEIA ACP — GS Medical Co., Ltd.NA — Synthes GmbHResponse 5.5/6.0 Cannulated Screw System — ORTHOPEDIATRICS CORP.Orthopediatrics Instrumentation — ORTHOPEDIATRICS CORP.NA — Synthes GmbHBroken Screw Removal Instruments — ORTHOPEDIATRICS CORP.NA — Synthes GmbHPIERMATTEI PIN DRIVER/BENDER — SONTEC INSTRUMENTS, INC.PIN DRIVER/BONE TAMP — SONTEC INSTRUMENTS, INC.Broken Screw Removal Instruments — ORTHOPEDIATRICS CORP.Consensus Knee System/Revision Knee System — Shalby Advanced Technologies, Inc.NA — aap Implantate AGBroken Screw Removal Instruments — ORTHOPEDIATRICS CORP.PETERSON PIN DRIVER/BENDER — SONTEC INSTRUMENTS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-09-09 | Zimmer, Inc. | The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cortical bone, and corresponding stripping of the 2.5mm Persona Hex |
| 2013-05-30 | Exactech, Inc. | When torque is applied to the Articulated Driver at the maximum angle, the cross pin may shift out of position, potentially leading to disassembly of the instru |
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