510(k) K092406 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
ABG II MODULAR HIP STEM
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Nov 4, 2009 |
| Received | Aug 6, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092406
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 26, 2012 | Stryker Howmedica Osteonics Corp. ABG II Modular Hip Stem
Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430
Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland.
The ABG II Modular range of implants is Open, Classified |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.