510(k) K010685 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM ARTICULAR SURFACE)
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Apr 2, 2001 |
| Received | Mar 8, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010685
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.