FDA 510(k)

Sistema de Espaçador Interbody Cervical Anterior ALTA

Número K: K160154 · 2016-05-13

Data da decisão2016-05-13

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ALTA Anterior Cervical Interbody Spacer is the device name listed in this FDA 510(k) record. The listed applicant is Astura Medical. It received FDA 510(k) clearance on 2016-05-13 under 510(k) number K160154. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ALTA Anterior Cervical Interbody Spacer?

ALTA Anterior Cervical Interbody Spacer is a medical device that received FDA 510(k) clearance on 2016-05-13. The listed applicant is Astura Medical. The 510(k) number is K160154.

When did ALTA Anterior Cervical Interbody Spacer receive FDA 510(k) clearance?

ALTA Anterior Cervical Interbody Spacer received FDA 510(k) clearance on 2016-05-13, under 510(k) number K160154.

Who is the listed applicant for ALTA Anterior Cervical Interbody Spacer?

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

What is the FDA product code for ALTA Anterior Cervical Interbody Spacer?

The FDA product code for ALTA Anterior Cervical Interbody Spacer is ODP.

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Fonte oficial

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