510(k) K983404 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
TYPE 3 FEMORAL COMPONENTS
| Applicant | Howmedica Corp., Rutherford NJ, US |
| Decision | Substantially Equivalent, Dec 22, 1998 |
| Received | Sep 28, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983404
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Stryker Howmedica Osteonics Restoration T3 Revision Hip System, Femoral Hip Prosthesis. Various lengths and Model numbers.
6260-3-014 T3 MOD REV DIST STM 14MMX225MM;
6260-3-015 T3 MOD REV DIST STM 15MMX225MM;
6260-3-016 Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.