510(k) K211883 · HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
QUANTUM® Patient Specific Instrumentation (PSI) System
| Applicant | In2bones Sas, Ecully, FR |
| Decision | Substantially Equivalent, Aug 11, 2021 |
| Received | Jun 21, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211883
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.