510(k) K936127 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
HOWMEDICA PREMIUM FEMORAL COMPONENT
| Applicant | Howmedica, Inc., Rutherford NJ, US |
| Decision | Substantially Equivalent, Oct 26, 1994 |
| Received | Dec 23, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K936127
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2012 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp. Str Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.