510(k) K213905 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
ONX Large External Fixation System
| Applicant | Orthonovis, Inc., Palm Coast FL, US |
| Decision | Substantially Equivalent, Aug 25, 2022 |
| Received | Dec 14, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213905
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.