510(k) K093472 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
TRINITY ACETABULAR SYSTEM
| Applicant | Corin USA, Tampa FL, US |
| Decision | Substantially Equivalent, Nov 23, 2010 |
| Received | Nov 6, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093472
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2021 | Corin Ltd Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321.035, Sterile; and Corin Trinity Screw, diameter 6.5mm 50mm Length, Cancellous Bone Screw, REF 321.050, Sterile, both are Terminated |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.