510(k) K063822 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
MODIFICATION TO HIPSTAR FEMORAL STEM
| Applicant | Stryker Orthopaedics, Mahwah NJ, US |
| Decision | Substantially Equivalent, Jan 25, 2007 |
| Received | Dec 26, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063822
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2007 | Stryker Howmedica Osteonics Corp. Hipstar V40 Femoral Stem-127 degrees; Catalog No: 7850-5-001, N degrees 3 high offset 31 mm;Sterile; IMPLANT SIZE 1, Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.