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FDA 510(k)

Foot and Ankle System

K-Number: K200062 · 2021-02-22

ApplicantLeith Medical, LLC
Decision Date2021-02-22
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Foot and Ankle System is the device name listed in this FDA 510(k) record. The listed applicant is Leith Medical, LLC. It received FDA 510(k) clearance on 2021-02-22 under 510(k) number K200062. 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 Foot and Ankle System?

Foot and Ankle System is a medical device that received FDA 510(k) clearance on 2021-02-22. The listed applicant is Leith Medical, LLC. The 510(k) number is K200062.

When did Foot and Ankle System receive FDA 510(k) clearance?

Foot and Ankle System received FDA 510(k) clearance on 2021-02-22, under 510(k) number K200062.

Who is the listed applicant for Foot and Ankle System?

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

What is the FDA product code for Foot and Ankle System?

The FDA product code for Foot and Ankle System is HRS.

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

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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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