510(k) K031744 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
OMNIFIT HFX HIP STEM SERIES
| Applicant | Howmedica Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Aug 8, 2003 |
| Received | Jun 5, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031744
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2009 | Stryker Howmedica Osteonics Corp. Omnifit HFX 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 total hip Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.