Mesh, Surgical, Acetabular, Hip, Prosthesis

FDA product code JDJ · Class II (moderate risk) · 21 CFR 878.3300 · General, Plastic Surgery

7510(k) clearances
0PMA approvals
0recalls
Implantimplanted device

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K972760Link, Acetabular Revision Mesh CupJDJ · Traditional Link America, Inc.10/22/1997SE
K970957Osteonics Restoration Acetabular RingJDJ · Traditional Osteonics Corp.06/03/1997SE
K963940Exeter MeshJDJ · Traditional Howmedica, Inc.02/13/1997SE
K962541Reflection Acetabular Reinforcement RingsJDJ · Traditional Smith & Nephew Richards, Inc.09/17/1996SE
K962007Protrusion CagesJDJ · Traditional Depuy, Inc.08/01/1996SE
K925883Osteonics Microstructured Acetabular ComponentsJDJ · Traditional Osteonics Corp.06/15/1993SE
K890450Intermedics Apr(Tm) II Femoral ComponentJDJ · Traditional Intermedics Orthopedics08/09/1989SN