FDA 510(k)

Destiknee Total Knee System

Número K: K160771 · 2016-12-19

RequerenteMeril Healthcare Private Limited

Data da decisão2016-12-19

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Destiknee Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Meril Healthcare Private Limited. It received FDA 510(k) clearance on 2016-12-19 under 510(k) number K160771. 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 Destiknee Total Knee System?

Destiknee Total Knee System is a medical device that received FDA 510(k) clearance on 2016-12-19. The listed applicant is Meril Healthcare Private Limited. The 510(k) number is K160771.

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

Destiknee Total Knee System received FDA 510(k) clearance on 2016-12-19, under 510(k) number K160771.

Who is the listed applicant for Destiknee Total Knee System?

The FDA 510(k) record lists Meril Healthcare Private Limited as the applicant. This does not by itself establish the device manufacturer.

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

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

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Fonte oficial

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