510(k) K160895 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Initia Total Hip System & BIOCERAM AZUL(R) HEAD
| Applicant | Kyocera Medical Corporation, Yodogawa-Ku, JP |
| Decision | Substantially Equivalent, Nov 1, 2016 |
| Received | Mar 31, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160895
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.