FDA 510(k)

EXPERT - Joint Fixation System

Número K: K200332 · 2020-10-29

RequerenteGM Dos Reis Industria e Comercio Ltda.

Data da decisão2020-10-29

Código do produtoHTN

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

EXPERT - Joint Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. It received FDA 510(k) clearance on 2020-10-29 under 510(k) number K200332. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EXPERT - Joint Fixation System?

EXPERT - Joint Fixation System is a medical device that received FDA 510(k) clearance on 2020-10-29. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. The 510(k) number is K200332.

When did EXPERT - Joint Fixation System receive FDA 510(k) clearance?

EXPERT - Joint Fixation System received FDA 510(k) clearance on 2020-10-29, under 510(k) number K200332.

Who is the listed applicant for EXPERT - Joint Fixation System?

The FDA 510(k) record lists GM Dos Reis Industria e Comercio Ltda. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXPERT - Joint Fixation System?

The FDA product code for EXPERT - Joint Fixation System is HTN.

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Fonte oficial

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