510(k) K140423 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
| Applicant | Conformis, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, May 27, 2014 |
| Received | Feb 18, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140423
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2014 | ConforMIS, Inc. Conformis iTotal CR G2 Knee Replacement System
Catalog/Model #: M57250600010
Intended for use as a total knee replacement in patients with knee joint pain and disability. Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.