510(k) K253764 ยท OSN Software For Diagnosis/Treatment
ENOS Software Guided External Fixation System
| Applicant | Disior, Ltd., Helsinki Uusimaa FL, US |
| Decision | Substantially Equivalent, Feb 26, 2026 |
| Received | Nov 25, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253764
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.