510(k) K122985 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
COLUMBUS REVISION KNEE SYSTEM
| Applicant | Aesculap Implant System, Inc., Center Valley PA, US |
| Decision | Substantially Equivalent, Oct 26, 2012 |
| Received | Sep 26, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122985
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 13, 2013 | Aesculap, Inc. Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7 Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.