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FDA 510(k)

Arthrex Patella SuturePlates

K-Number: K203834 · 2021-03-25

ApplicantArthrex, Inc.
Decision Date2021-03-25
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Patella SuturePlates is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2021-03-25 under 510(k) number K203834. 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 Patella SuturePlates?

Arthrex Patella SuturePlates is a medical device that received FDA 510(k) clearance on 2021-03-25. The listed applicant is Arthrex, Inc.. The 510(k) number is K203834.

When did Arthrex Patella SuturePlates receive FDA 510(k) clearance?

Arthrex Patella SuturePlates received FDA 510(k) clearance on 2021-03-25, under 510(k) number K203834.

Who is the listed applicant for Arthrex Patella SuturePlates?

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 Patella SuturePlates?

The FDA product code for Arthrex Patella SuturePlates 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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