510(k) K120578 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
ACCOLADE II HIP STEM
| Applicant | Howmedica Osteonics, Mahwah NJ, US |
| Decision | Substantially Equivalent, Mar 29, 2012 |
| Received | Feb 27, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120578
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 7, 2013 | Stryker Howmedica Osteonics Corp. 1) Accolade II 127 Neck Angle Hip Stem, Size # 3
2) Accolade II 127 Neck Angle Hip Stem, Size #5
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 USA
Telephone # +1 201-831-5000
Stryk Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.