510(k) K092561 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
REJUVENATE MODULAR STEM
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Oct 20, 2009 |
| Received | Aug 21, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092561
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 26, 2012 | Stryker Howmedica Osteonics Corp. Rejuvenate Modular Stems
Stryker Ireland Carrigtwohill Industrial Estate
Carrigtwohill County Cork, Ireland
Rejuvenate Modular Necks Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430.
Stem Bodies Open, Classified |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.