510(k) K080647 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
ACCIN BIPOLAR HEAD SYSTEM
| Applicant | Accelerated Innovation, LLC, Clifton NJ, US |
| Decision | Substantially Equivalent, Jul 8, 2008 |
| Received | Mar 7, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080647
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.