510(k) K070292 ยท KXA Prosthesis, Hip, Femoral, Resurfacing
DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS
| Applicant | Zimmer GmbH, Warsaw IN, US |
| Decision | Substantially Equivalent, Apr 26, 2007 |
| Received | Jan 31, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070292
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2012 | Zimmer, Inc. Metasul Durom Femoral component
Sterile, Rx Terminated |
KXA | None listed |
| Nov 29, 2007 | Zimmer Inc. Zimmer Durom Hip Resurfacing Systems, Femoral Component 54 Code T; Catalog No.: 01.00211.154, Zimmer, Warsaw, IN, 46581-0708. Terminated |
KXA | None listed |
| Nov 29, 2007 | Zimmer Inc. Zimmer Durom Hip Resurfacing Systems, Femoral Component 46 Code L; Catalog No.: 01.00211.146, Lot 2376766. Zimmer, Warsaw, IN, 46581-0708. Terminated |
KXA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.