510(k) K150544 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System
| Applicant | Aesculap Implant Systems, LLC, Center Valley PA, US |
| Decision | Substantially Equivalent, May 29, 2015 |
| Received | Mar 3, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K150544
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.