510(k) K060192 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
APEX KNEE SYSTEM
| Applicant | Omni Life Science, Inc., Raynham MA, US |
| Decision | Substantially Equivalent, Jun 15, 2006 |
| Received | Jan 25, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060192
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 20, 2017 | OMNIlife science Inc. Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L
The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intende Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.