K253764
- 510(k) number
- K253764
- Device name
- ENOS Software Guided External Fixation System
- Applicant
- Disior, Ltd. FL · US
- Product code
- OSN — Software For Diagnosis/Treatment
- Decision date
- 2026-02-26
- Date received
- 2025-11-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K253764.pdf
Official FDA record: K253764
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.