510(k) K963148 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
NEXGEN COMPLETE KNEE SOLUTION
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Feb 13, 1997 |
| Received | Aug 13, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963148
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 22, 2006 | Zimmer Inc. Zimmer NexGen Complete Knee Solution Legacy Knee Tibial Component, 3 degree, fluted, size 4, stemmed option, for cemented use only, tivanium TI-6AL-4V alloy/UHMWPE, sterile; Catalog no. 05-5998-038-02 Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.