510(k) K120507 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
UNITED U2 FEMORAL COMPONENT, PS, #7
| Applicant | United Orthopedic Corporation, Hsinchu, TW |
| Decision | Substantially Equivalent, May 4, 2012 |
| Received | Feb 21, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120507
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 24, 2013 | Orthopedic Alliance LLC Femoral component, CR, cemented, #1, left 2103-1310
Femoral component, CR, cemented, #2, left 2103-1320
Femoral component, CR, cemented, #3, left 2103-1330
Femoral component, CR, cemented, #4, left 21 Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.