510(k) K983226 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
OSTEONICS X CEMENTED HIP STEM SERIES
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Dec 4, 1998 |
| Received | Sep 15, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983226
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2009 | Stryker Howmedica Osteonics Corp. Omnifit FC Cemented 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 Terminated |
JDI | None listed |
| Jan 26, 2009 | Stryker Howmedica Osteonics Corp. Omnifit Eon
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 arthropl Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.