Plate, Fixation, Bone, Non-Spinal, Metallic

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

3510(k) clearances
0PMA approvals
1recalls
Implantimplanted device

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K051642Fr.O.H. Calcaneus Repair SystemNDF · Traditional I.T.S. Implantat-Technologie-Systeme GmbH08/22/2005SE
K021749Ebi Dynafix VS Osteotomy SystemNDF · Traditional Ebi, L.P.08/12/2002SE
K010551Ebi Dynafix VS Osteotomy SystemNDF · Traditional Ebi, L.P.05/17/2001SE

Recalls

RecallProductFirmInitiated
Z-1015-2014 Class IIDISTAL MEDIAL FEMORAL CON, DISTAL POSTERIOR/LATERAL, DISTAL SMALL VOLAR RADIUS, PROXIMAL…Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… Zimmer, Inc.10/11/2013Terminated