510(k) K051640 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
U2 TOTAL KNEE SYSTEM
| Applicant | United Orthopedic Corp., Hsinchu, TW |
| Decision | Substantially Equivalent, Mar 1, 2006 |
| Received | Jun 20, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051640
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 24, 2017 | United Orthopedic Corporation U2 Total Knee System Tibial Insert, Posterior Stabilized, #3,
11mm Thick Catalogue number 2303-3032
The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or i Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.