FDA 510(k)

Arthrex Univers Revers Shoulder Prosthesis System

Número K: K161782 · 2016-11-21

Data da decisão2016-11-21

Código do produtoHSD

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Arthrex Univers Revers Shoulder Prosthesis System is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2016-11-21 under 510(k) number K161782. The device is classified under product code HSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Arthrex Univers Revers Shoulder Prosthesis System?

Arthrex Univers Revers Shoulder Prosthesis System is a medical device that received FDA 510(k) clearance on 2016-11-21. The listed applicant is Arthrex, Inc.. The 510(k) number is K161782.

When did Arthrex Univers Revers Shoulder Prosthesis System receive FDA 510(k) clearance?

Arthrex Univers Revers Shoulder Prosthesis System received FDA 510(k) clearance on 2016-11-21, under 510(k) number K161782.

Who is the listed applicant for Arthrex Univers Revers Shoulder Prosthesis System?

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

What is the FDA product code for Arthrex Univers Revers Shoulder Prosthesis System?

The FDA product code for Arthrex Univers Revers Shoulder Prosthesis System is HSD.

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Fonte oficial

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