FDA 510(k)

Sistema de Artrólise de Lapidus AlignMATE®

Número K: K162391 · 2017-02-21

Data da decisão2017-02-21

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

AlignMATE™ Lapidus Arthrodesis System is the device name listed in this FDA 510(k) record. The listed applicant is Arthrosurface, Inc.. It received FDA 510(k) clearance on 2017-02-21 under 510(k) number K162391. 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 AlignMATE™ Lapidus Arthrodesis System?

AlignMATE™ Lapidus Arthrodesis System is a medical device that received FDA 510(k) clearance on 2017-02-21. The listed applicant is Arthrosurface, Inc.. The 510(k) number is K162391.

When did AlignMATE™ Lapidus Arthrodesis System receive FDA 510(k) clearance?

AlignMATE™ Lapidus Arthrodesis System received FDA 510(k) clearance on 2017-02-21, under 510(k) number K162391.

Who is the listed applicant for AlignMATE™ Lapidus Arthrodesis System?

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

What is the FDA product code for AlignMATE™ Lapidus Arthrodesis System?

The FDA product code for AlignMATE™ Lapidus Arthrodesis System is HRS.

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Fonte oficial

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