510(k) K071471 ยท KWL Prosthesis, Hip, Hemi-, Femoral, Metal
CORIN ADAPTOR SLEEVE
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Sep 10, 2007 |
| Received | May 29, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071471
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Corin Unipolar Adapter Sleeve, For use with Corin Unipolar CoCr Heads; Not for use w/ceramic heads; not for use w/ Stainless Steel implants.
Stryker Orthopaedics.
Indicated for use in partial hip rep Terminated |
KWL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.