510(k) K082525 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
CORIN METAFIX FEMORAL STEM
| Applicant | Corin USA, Tampa FL, US |
| Decision | Substantially Equivalent, Feb 4, 2010 |
| Received | Sep 2, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082525
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 22, 2022 | Corin Ltd Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103 Open, Classified |
JDI | None listed |
| Jul 28, 2021 | Corin Ltd Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201, Sterile. Terminated |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.