ENOS Software Guided External Fixation System— 510(k) K253764

Name: FDA 510(k) clearance K253764
Creator: U.S. Food and Drug Administration
Published: 2026-02-26

Substantially Equivalent

Disior, Ltd.

FDA 510(k) clearance K253764 for ENOS Software Guided External Fixation System, Substantially Equivalent on 2026-02-26. Applicant: Disior, Ltd.. Device class: 2.

Clearance details

Applicant: Disior, Ltd.
Product code: Code OSN
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2025-11-25
Decision date: 2026-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki Uusimaa, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.