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FDA 510(k)

Arthrex Small External Fixation System

K-Number: K232897 · 2023-10-18

ApplicantArthrex, Inc.
Decision Date2023-10-18
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Small External Fixation System is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2023-10-18 under approval number K232897. 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 Arthrex Small External Fixation System?

Arthrex Small External Fixation System is a medical device that received FDA 510(k) clearance on 2023-10-18. It is manufactured by Arthrex, Inc.. The 510(k) number is K232897.

When was Arthrex Small External Fixation System approved by the FDA?

Arthrex Small External Fixation System received FDA 510(k) clearance on 2023-10-18, under approval number K232897.

What company makes Arthrex Small External Fixation System?

Arthrex Small External Fixation System is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Small External Fixation System?

The FDA product code for Arthrex Small External Fixation System is KTT.

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Official Source

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