FDA 510(k)

Foot and Ankle System

Número K: K200062 · 2021-02-22

Data da decisão2021-02-22

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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