510(k) K180317 · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
EVOLUTION® Knee Systems MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System
| Applicant | Microport Orthopedics, Inc., Arlington TN, US |
| Decision | Substantially Equivalent, May 4, 2018 |
| Received | Feb 5, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180317
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.