510(k) K163311 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
GMK Revision Femoral Distal Augmentation
| Applicant | Medacta International S.A., Castel San Pietro (Ch), CH |
| Decision | Substantially Equivalent, Dec 21, 2016 |
| Received | Nov 23, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163311
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.