510(k) K042757 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
VANGUARD SSK KNEE SYSTEM
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Feb 11, 2005 |
| Received | Oct 4, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042757
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2017 | Zimmer Biomet, Inc. various polyethylene implants
Knees
Revision Tibial Tray Systems
Oxford Partial Knee
Orthopedic Salvage System
Vanguard Complete Knee System
Vanguard SSK Revision System
Biomet Patella
Maxim Complete Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.