FDA 510(k)

Sistema de Placa Cervical Anterior

Número K: K151553 · 2016-02-10

Data da decisão2016-02-10

Código do produtoKWQ

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed Implantes, Ltda. It received FDA 510(k) clearance on 2016-02-10 under 510(k) number K151553. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Anterior Cervical Plate System?

Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2016-02-10. The listed applicant is Osteomed Implantes, Ltda. The 510(k) number is K151553.

When did Anterior Cervical Plate System receive FDA 510(k) clearance?

Anterior Cervical Plate System received FDA 510(k) clearance on 2016-02-10, under 510(k) number K151553.

Who is the listed applicant for Anterior Cervical Plate System?

The FDA 510(k) record lists Osteomed Implantes, Ltda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anterior Cervical Plate System?

The FDA product code for Anterior Cervical Plate System is KWQ.

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