510(k) K063633 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES
| Applicant | DePuy Orthopaedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 2, 2007 |
| Received | Dec 6, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063633
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 8, 2021 | DePuy Orthopaedics, Inc. Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products. Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.