510(k) K123991 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
DEPUY CORAIL AMT HIP PROSTHESIS
| Applicant | Depuy France S.A.S., Warsaw IN, US |
| Decision | Substantially Equivalent, Sep 16, 2013 |
| Received | Dec 26, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123991
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2018 | DePuy Orthopaedics, Inc. CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511 Terminated |
KWL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.