510(k) K200112 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Zimmer Hip Joint Replacement
| Applicant | Zimmer GmbH, Winterthur, CH |
| Decision | Substantially Equivalent, Apr 10, 2020 |
| Received | Jan 17, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200112
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2023 | Biomet, Inc. Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01 Open, Classified |
LZO | None listed |
| Dec 18, 2023 | Biomet, Inc. Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02 Open, Classified |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.