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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 the device name listed in this FDA 510(k) record. The listed applicant is Disior, Ltd.. It received FDA 510(k) clearance on 2026-02-26 under 510(k) 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. The listed applicant is Disior, Ltd.. The 510(k) number is K253764.

When did ENOS Software Guided External Fixation System receive FDA 510(k) clearance?

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

Who is the listed applicant for ENOS Software Guided External Fixation System?

The FDA 510(k) record lists Disior, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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Other records listing Disior, Ltd. as applicant

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Related Devices (Code: 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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