FDA 510(k)

Sistema de Ombro Anatômico, Sistema de Domelock de Ombro Anatômico, Sistema de Fratura de Ombro Anatômico

Número K: K160085 · 2016-03-08

Data da decisão2016-03-08

Código do produtoKWS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2016-03-08 under 510(k) number K160085. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System?

Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System is a medical device that received FDA 510(k) clearance on 2016-03-08. The listed applicant is Zimmer GmbH. The 510(k) number is K160085.

When did Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System receive FDA 510(k) clearance?

Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System received FDA 510(k) clearance on 2016-03-08, under 510(k) number K160085.

Who is the listed applicant for Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System?

The FDA 510(k) record lists Zimmer GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System?

The FDA product code for Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System is KWS.

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Fonte oficial

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