510(k) K170845 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
MiniMAX
| Applicant | Medacta International S.A., Castel San Pietro (Ch), CH |
| Decision | Substantially Equivalent, Aug 8, 2017 |
| Received | Mar 21, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170845
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2017 | Medacta Usa Inc Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery. Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.