510(k) K230462 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
OPTIX H2 Patient Specific Instrument System
| Applicant | Vilex, LLC, Mcminnville TN, US |
| Decision | Substantially Equivalent, Jul 17, 2023 |
| Received | Feb 21, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230462
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.