510(k) K200959 · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling
| Applicant | Biomet UK, Ltd., Brigend, GB |
| Decision | Substantially Equivalent, Jul 29, 2020 |
| Received | Apr 10, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200959
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.