510(k) K962448 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
PRIMALOC CEMENTED HIP SYSTEM
| Applicant | Ortho Development Corp., Draper UT, US |
| Decision | Substantially Equivalent for Some Indications, Sep 19, 1996 |
| Received | Jun 24, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962448
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2010 | Ortho Development Corporation Distal Centralizer 10 mm Terminated |
KWY | None listed |
| Feb 25, 2003 | Ortho Development Corporation Hip Prosthesis as a component of Primaloc Cemented Hip System. Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.