510(k) K974685 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Sep 22, 1998 |
| Received | Dec 16, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974685
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2019 | Howmedica Osteonics Corp. Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum
Catalog #: 2041C-3254 Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.