FDA 510(k)

Omni Foot Plating System

Número K: K180808 · 2018-05-22

Data da decisão2018-05-22

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Omni Foot Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Extremity Medical, LLC. It received FDA 510(k) clearance on 2018-05-22 under 510(k) number K180808. 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 Plating System?

Omni Foot Plating System is a medical device that received FDA 510(k) clearance on 2018-05-22. The listed applicant is Extremity Medical, LLC. The 510(k) number is K180808.

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

Omni Foot Plating System received FDA 510(k) clearance on 2018-05-22, under 510(k) number K180808.

Who is the listed applicant for Omni Foot Plating System?

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

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

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

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Fonte oficial

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