510(k) K093644 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
RESTORATION ADM SYSTEM X3 ACETABULAR
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Dec 18, 2009 |
| Received | Nov 25, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093644
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2011 | Stryker Howmedica Osteonics Corp. Stryker Restoration ADM System X3 Acetabular Insert Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; Stryker France ZAC Satolos Green Pusignan Av de Satolas Green 69881 Mey Sieu Cedex Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.