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FDA 510(k)

Arthrex 2.4 mm Volar Distal Radius Plate System

K-Number: K222267 · 2022-10-03

ApplicantArthrex, Inc.
Decision Date2022-10-03
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex 2.4 mm Volar Distal Radius Plate 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 2022-10-03 under 510(k) number K222267. 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 2.4 mm Volar Distal Radius Plate System?

Arthrex 2.4 mm Volar Distal Radius Plate System is a medical device that received FDA 510(k) clearance on 2022-10-03. The listed applicant is Arthrex, Inc.. The 510(k) number is K222267.

When did Arthrex 2.4 mm Volar Distal Radius Plate System receive FDA 510(k) clearance?

Arthrex 2.4 mm Volar Distal Radius Plate System received FDA 510(k) clearance on 2022-10-03, under 510(k) number K222267.

Who is the listed applicant for Arthrex 2.4 mm Volar Distal Radius Plate 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 2.4 mm Volar Distal Radius Plate System?

The FDA product code for Arthrex 2.4 mm Volar Distal Radius Plate System is HRS.

Other records listing Arthrex, Inc. as applicant

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Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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