510(k) K230313 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
QUANTUM Patient Specific Instrumentation (PSI) System
| Applicant | In2bones Sas, Ecully, FR |
| Decision | Substantially Equivalent, Apr 6, 2023 |
| Received | Feb 6, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230313
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.