510(k) K103733 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
UNITED U2 XPE TOTAL KNEE SYSTEM
| Applicant | United Orthopedic Corporation, Hsinchu, TW |
| Decision | Substantially Equivalent, Aug 2, 2011 |
| Received | Dec 22, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103733
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 24, 2013 | Orthopedic Alliance LLC Tibial baseplate,cemented,#1 2203-3010
Tibial baseplate,cemented,#2 2203-3020
Tibial baseplate,cemented,#3 2203-3030
Tibial baseplate,cemented,#4 2203-3040
Tibial baseplate, cemented, #5 2203-3050
Tib Terminated |
JWH | None listed |
| May 24, 2013 | Orthopedic Alliance LLC UKNEE Patella,small 2401-1010
UKNEE Patella,medium 2401-1020
UKNEE Patella,large 2401-1030
UKNEE Patella,X-large 2401-1040
UKNEE Onset Patella, 3 pegs, x-small 2403-1010
UKNEE Onset Patella, 3 pegs, Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.