510(k) K100900 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
MOTIVATION KNEE SYSTEM
| Applicant | Encore Medical L.P., Austin TX, US |
| Decision | Substantially Equivalent, Jun 18, 2010 |
| Received | Mar 31, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100900
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2017 | Encore Medical, Lp DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE,
REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery. Terminated |
JWH | None listed |
| Dec 12, 2017 | Encore Medical, Lp EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthopedic surgery. Terminated |
JWH | None listed |
| Dec 12, 2017 | Encore Medical, Lp EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery. Terminated |
JWH | None listed |
| Dec 12, 2017 | Encore Medical, Lp EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthopedic surgery. Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.