510(k) K201072 ยท KYI Prosthesis, Wrist, Carpal Trapezium
Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161
| Applicant | Ensemble Orthopedics, LLC, Austin TX, US |
| Decision | Substantially Equivalent, Dec 2, 2020 |
| Received | Apr 22, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201072
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.