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FDA 510(k)

Arthrex Mesh Plates

K-Number: K201677 · 2020-09-02

ApplicantArthrex, Inc.
Decision Date2020-09-02
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Mesh Plates is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2020-09-02 under 510(k) number K201677. 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 Mesh Plates?

Arthrex Mesh Plates is a medical device that received FDA 510(k) clearance on 2020-09-02. The listed applicant is Arthrex, Inc.. The 510(k) number is K201677.

When did Arthrex Mesh Plates receive FDA 510(k) clearance?

Arthrex Mesh Plates received FDA 510(k) clearance on 2020-09-02, under 510(k) number K201677.

Who is the listed applicant for Arthrex Mesh Plates?

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 Mesh Plates?

The FDA product code for Arthrex Mesh Plates is HRS.

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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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