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FDA 510(k)

Arthrex Mini Fragment System

K-Number: K220937 · 2022-06-29

ApplicantArthrex, Inc.
Decision Date2022-06-29
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Mini Fragment System is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2022-06-29 under approval number K220937. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex Mini Fragment System?

Arthrex Mini Fragment System is a medical device that received FDA 510(k) clearance on 2022-06-29. It is manufactured by Arthrex, Inc.. The 510(k) number is K220937.

When was Arthrex Mini Fragment System approved by the FDA?

Arthrex Mini Fragment System received FDA 510(k) clearance on 2022-06-29, under approval number K220937.

What company makes Arthrex Mini Fragment System?

Arthrex Mini Fragment System is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Mini Fragment System?

The FDA product code for Arthrex Mini Fragment System is HRS.

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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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