510(k) K970284 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
ARTOS, DIPLOS SYSTEM
| Applicant | Turnkey Intergration USA, Inc., Sarasota FL, US |
| Decision | Substantially Equivalent, Apr 21, 1997 |
| Received | Jan 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970284
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.