FDA 510(k)

Sistema de Quadril Total A3

Número K: K180493 · 2018-06-22

Data da decisão2018-06-22

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

A3 Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Beijing AK Medical Co., Ltd.. It received FDA 510(k) clearance on 2018-06-22 under 510(k) number K180493. 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 A3 Total Knee System?

A3 Total Knee System is a medical device that received FDA 510(k) clearance on 2018-06-22. The listed applicant is Beijing AK Medical Co., Ltd.. The 510(k) number is K180493.

When did A3 Total Knee System receive FDA 510(k) clearance?

A3 Total Knee System received FDA 510(k) clearance on 2018-06-22, under 510(k) number K180493.

Who is the listed applicant for A3 Total Knee System?

The FDA 510(k) record lists Beijing AK Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A3 Total Knee System?

The FDA product code for A3 Total Knee System is JWH.

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Dispositivos Relacionados (Código: JWH)

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Fonte oficial

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