510(k) K190136 ยท KWH Prosthesis, Toe, Constrained, Polymer
Fusion Silastic System
| Applicant | Fusion Orthopedics, LLC, Mesa AZ, US |
| Decision | Substantially Equivalent, Oct 21, 2019 |
| Received | Jan 29, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190136
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.