510(k) K123705 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS
| Applicant | Corin USA, Tampa FL, US |
| Decision | Substantially Equivalent, Feb 12, 2013 |
| Received | Dec 3, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123705
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2021 | Corin Ltd Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, REF 320.03.350, Sterile, a component of the Trinity Acetabular System. Terminated |
MEH | None listed |
| Jan 29, 2016 | Corin USA Limited Trinity Acetabular System
Product Usage - Total Hip Replacement. Terminated |
LZO | None listed |
| Jan 29, 2016 | Corin USA Limited Trinity Acetabular Shell
Product Usage: Total Hip Replacement. Terminated |
LZO | None listed |
| Jan 29, 2016 | Corin USA Limited Trinity Acetabular Shell
Product Usage Total Hip Replacement. Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.