510(k) K152439 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
U2 Bipolar Implant and 22mm Femoral Head
| Applicant | United Orthopedic Corporation, Hsinchu, TW |
| Decision | Substantially Equivalent, Apr 7, 2016 |
| Received | Aug 27, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152439
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.