510(k) K041046 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
MAXIM ACCEL (VANGUARD) PS+ BEARINGS
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, May 21, 2004 |
| Received | Apr 22, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041046
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2008 | Biomet, Inc. Biomet Vanguard(TM) DCM PS Plus 16mm x 63/67mm Tibial Bearing (REF. 183726), ARCOM UHMWPE, sterile, Biomet Orthopedics, Inc., Warsaw, IN.
A knee prosthesis intended for single use implantation to rep Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.