510(k) K003316 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
OTI CERAMIC FEMORAL HEAD SYSTEM
| Applicant | Osteoimplant Technology, Inc., Hunt Valley MD, US |
| Decision | Substantially Equivalent, Jan 19, 2001 |
| Received | Oct 23, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003316
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.