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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 the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2022-06-29 under 510(k) 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. The listed applicant is Arthrex, Inc.. The 510(k) number is K220937.

When did Arthrex Mini Fragment System receive FDA 510(k) clearance?

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

Who is the listed applicant for Arthrex Mini Fragment System?

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

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

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

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