510(k) K123604 ยท MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
ABG III MONOLITHIC HIP STEM
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Aug 16, 2013 |
| Received | Nov 21, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123604
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2016 | Stryker Howmedica Osteonics Corp. Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm
Product Usage:
Intended for the temporary stabilization of bone segments or fragments. Terminated |
MAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.