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FDA 510(k)

Arthrx Fracture Plates

K-Number: K213837 · 2022-05-02

ApplicantArthrex, Inc.
Decision Date2022-05-02
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrx Fracture 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 2022-05-02 under 510(k) number K213837. 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 Arthrx Fracture Plates?

Arthrx Fracture Plates is a medical device that received FDA 510(k) clearance on 2022-05-02. The listed applicant is Arthrex, Inc.. The 510(k) number is K213837.

When did Arthrx Fracture Plates receive FDA 510(k) clearance?

Arthrx Fracture Plates received FDA 510(k) clearance on 2022-05-02, under 510(k) number K213837.

Who is the listed applicant for Arthrx Fracture 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 Arthrx Fracture Plates?

The FDA product code for Arthrx Fracture Plates 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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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