510(k) K170359 · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Trinity Dual Mobility System
| Applicant | Corin U.S.A. Limited, Tampa FL, US |
| Decision | Substantially Equivalent, Oct 31, 2017 |
| Received | Feb 6, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170359
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2021 | Corin Ltd Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540, Sterile, and Corin Dual Mobility, Size 4 42 insert/28 head, REF 325.04.042, Sterile; both are components of the Trinity D Terminated |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.