FDA 510(k)

Omni Foot and Ankle Plating System

Número K: K221362 · 2022-06-10

Data da decisão2022-06-10

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Omni Foot and Ankle Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Exremity Medical, LLC. It received FDA 510(k) clearance on 2022-06-10 under 510(k) number K221362. 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 Omni Foot and Ankle Plating System?

Omni Foot and Ankle Plating System is a medical device that received FDA 510(k) clearance on 2022-06-10. The listed applicant is Exremity Medical, LLC. The 510(k) number is K221362.

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

Omni Foot and Ankle Plating System received FDA 510(k) clearance on 2022-06-10, under 510(k) number K221362.

Who is the listed applicant for Omni Foot and Ankle Plating System?

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

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

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

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Fonte oficial

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