510(k) K112463 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
UNITED 36MM CERAMIC FEMORAL HEAD, DELTA
| Applicant | United Orthopedic Corporation, Hsinchu, TW |
| Decision | Substantially Equivalent, Sep 23, 2011 |
| Received | Aug 26, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112463
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 24, 2013 | Orthopedic Alliance LLC Ball Head, 28 Short CERAMIC
Ball Head, 28 Medium CERAMIC
Ball Head, 28 Long CERAMIC
Ball Head, 32 Short CERAMIC
Ball Head, 32 Medium CERAMIC
Ball Head, 32 Long CERAMIC
Ball Head, 28 Short CoCr
Ball He Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.