510(k) K053299 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT
| Applicant | Biomet Manufacturing, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jan 5, 2006 |
| Received | Nov 25, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053299
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.