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FDA 510(k)

ENOS Software Guided External Fixation System

K-Number: K253764 · 2026-02-26

ApplicantDisior, Ltd.
Decision Date2026-02-26
Product CodeOSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENOS Software Guided External Fixation System is a medical device manufactured by Disior, Ltd.. It received FDA 510(k) clearance on 2026-02-26 under approval number K253764. The device is classified under product code OSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENOS Software Guided External Fixation System?

ENOS Software Guided External Fixation System is a medical device that received FDA 510(k) clearance on 2026-02-26. It is manufactured by Disior, Ltd.. The 510(k) number is K253764.

When was ENOS Software Guided External Fixation System approved by the FDA?

ENOS Software Guided External Fixation System received FDA 510(k) clearance on 2026-02-26, under approval number K253764.

What company makes ENOS Software Guided External Fixation System?

ENOS Software Guided External Fixation System is manufactured by Disior, Ltd..

What is the FDA product code for ENOS Software Guided External Fixation System?

The FDA product code for ENOS Software Guided External Fixation System is OSN.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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