510(k) K210961 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
U2 Total Knee System, XPE Tibial Insert, PS PLUS
| Applicant | United Orthopedic Corporation, Hsinchu City, TW |
| Decision | Substantially Equivalent, Apr 21, 2021 |
| Received | Mar 31, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K210961
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.