FDA 510(k)

Sistema de Ombro ASHCOM, Sistema de Ombro Anatômico e Sistema de Ombro Combinado Anatômico

Número K: K170711 · 2017-06-01

Data da decisão2017-06-01

Código do produtoPHX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined 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 2017-06-01 under 510(k) number K170711. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System?

ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System is a medical device that received FDA 510(k) clearance on 2017-06-01. The listed applicant is Zimmer GmbH. The 510(k) number is K170711.

When did ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System receive FDA 510(k) clearance?

ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System received FDA 510(k) clearance on 2017-06-01, under 510(k) number K170711.

Who is the listed applicant for ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined 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 ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System?

The FDA product code for ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System is PHX.

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Fonte oficial

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