510(k) K932519 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
OSTEONICS(R) OMNIFIT(R) NORMALIZED HIP STEM
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent for Some Indications, Mar 10, 1994 |
| Received | May 25, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K932519
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2009 | Stryker Howmedica Osteonics Corp. Omnifit Normalized Hip Stem
These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision to Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.