Condylar Plate Fixation Implant

FDA product code JDP · Class II (moderate risk) · 21 CFR 888.3030 · Orthopedic

2510(k) clearances
0PMA approvals
2recalls
Implantimplanted device

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…JDP · Traditional DePuy Synthes03/29/2017SE
K1103544.5MM Va-Lcp Curved Condylar Plate SystemJDP · Special Synthes USA03/04/2011SE

Recalls

RecallProductFirmInitiated
Z-1125-2014 Class IISynthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking…Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior… Synthes, Inc.02/05/2014Terminated
Z-0401-2014 Class IISynthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP…A plate was inadvertently released to a sales consultant that was restricted for sale. Synthes USA HQ, Inc.05/29/2013Terminated