FDA 510(k)

Versalock Periprosthetic Femur Plates System-GMReis

Número K: K201728 · 2021-03-08

RequerenteGM Dos Reis Industria e Comercio Ltda.

Data da decisão2021-03-08

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Versalock Periprosthetic Femur Plates System-GMReis 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 2021-03-08 under 510(k) number K201728. 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 Versalock Periprosthetic Femur Plates System-GMReis?

Versalock Periprosthetic Femur Plates System-GMReis is a medical device that received FDA 510(k) clearance on 2021-03-08. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. The 510(k) number is K201728.

When did Versalock Periprosthetic Femur Plates System-GMReis receive FDA 510(k) clearance?

Versalock Periprosthetic Femur Plates System-GMReis received FDA 510(k) clearance on 2021-03-08, under 510(k) number K201728.

Who is the listed applicant for Versalock Periprosthetic Femur Plates System-GMReis?

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 Versalock Periprosthetic Femur Plates System-GMReis?

The FDA product code for Versalock Periprosthetic Femur Plates System-GMReis is HRS.

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Fonte oficial

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