510(k) K131409 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
CAS PSI KNEE SYSTEM
| Applicant | Orthosoft, Inc., Montreal, CA |
| Decision | Substantially Equivalent, Sep 13, 2013 |
| Received | May 15, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131409
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2014 | Zimmer CAS PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer
The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the pos Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.