510(k) K201157 · MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Prime BIOFOAM® Multi-Hole Shells
| Applicant | Microport Orthopedics, Inc., Arlington TN, US |
| Decision | Substantially Equivalent, Aug 24, 2021 |
| Received | Apr 30, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201157
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.