510(k) K161360 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
U2 Total Knee System, PSA Tibial Insert
| Applicant | United Orthopedic Corporation, Hsinchu, TW |
| Decision | Substantially Equivalent, Feb 1, 2017 |
| Received | May 16, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161360
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.