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FDA 510(k)

Orthex External Fixation System

K-Number: K243798 · 2025-03-07

ApplicantOrthoPediatrics Corp.
Decision Date2025-03-07
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Orthex External Fixation System is a medical device manufactured by OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2025-03-07 under approval number K243798. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Orthex External Fixation System?

Orthex External Fixation System is a medical device that received FDA 510(k) clearance on 2025-03-07. It is manufactured by OrthoPediatrics Corp.. The 510(k) number is K243798.

When was Orthex External Fixation System approved by the FDA?

Orthex External Fixation System received FDA 510(k) clearance on 2025-03-07, under approval number K243798.

What company makes Orthex External Fixation System?

Orthex External Fixation System is manufactured by OrthoPediatrics Corp..

What is the FDA product code for Orthex External Fixation System?

The FDA product code for Orthex External Fixation System is KTT.

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Related Devices (Code: KTT)

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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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