Driver, Surgical, Pin

FDA product code GFC · Class I (low risk) · 21 CFR 878.4820 · General, Plastic Surgery

2510(k) clearances
0PMA approvals
2recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K781450DriversGFC · Traditional Orthopedic Equipment Co., Inc.09/27/1978SE
K780255Needle DriverGFC · Traditional Scanlan Intl., Inc.04/18/1978SE

Recalls

RecallProductFirmInitiated
Z-2737-2014 Class IIPersona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2.…The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cortical bone… Zimmer, Inc.09/09/2014Terminated
Z-1832-2013 Class IIExactech Articulated Driver A nonpowered hand-held device intended for medical purposes…When torque is applied to the Articulated Driver at the maximum angle, the cross pin may shift out of… Exactech, Inc.05/30/2013Terminated