FDA 510(k)

Genius / Genuin Total Knee System

Número K: K200765 · 2021-05-05

Data da decisão2021-05-05

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Genius / Genuin Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Biorad Medisys Pvt, Ltd.. It received FDA 510(k) clearance on 2021-05-05 under 510(k) number K200765. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Genius / Genuin Total Knee System?

Genius / Genuin Total Knee System is a medical device that received FDA 510(k) clearance on 2021-05-05. The listed applicant is Biorad Medisys Pvt, Ltd.. The 510(k) number is K200765.

When did Genius / Genuin Total Knee System receive FDA 510(k) clearance?

Genius / Genuin Total Knee System received FDA 510(k) clearance on 2021-05-05, under 510(k) number K200765.

Who is the listed applicant for Genius / Genuin Total Knee System?

The FDA 510(k) record lists Biorad Medisys Pvt, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Genius / Genuin Total Knee System?

The FDA product code for Genius / Genuin Total Knee System is JWH.

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Fonte oficial

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