510(k) K170288 · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell
| Applicant | Microport Orthopedics, Inc., Arlington TN, US |
| Decision | Substantially Equivalent, Jun 15, 2017 |
| Received | Jan 30, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170288
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.