FDA 510(k)

Dispositivos de Fusão Interespinais Amendia

Número K: K160924 · 2016-11-08

Data da decisão2016-11-08

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Amendia Interbody Fusion Devices is the device name listed in this FDA 510(k) record. The listed applicant is Amendia, Inc.. It received FDA 510(k) clearance on 2016-11-08 under 510(k) number K160924. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Amendia Interbody Fusion Devices?

Amendia Interbody Fusion Devices is a medical device that received FDA 510(k) clearance on 2016-11-08. The listed applicant is Amendia, Inc.. The 510(k) number is K160924.

When did Amendia Interbody Fusion Devices receive FDA 510(k) clearance?

Amendia Interbody Fusion Devices received FDA 510(k) clearance on 2016-11-08, under 510(k) number K160924.

Who is the listed applicant for Amendia Interbody Fusion Devices?

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

What is the FDA product code for Amendia Interbody Fusion Devices?

The FDA product code for Amendia Interbody Fusion Devices is MAX.

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Outros registros que listam Amendia, Inc. como candidato(a)

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Dispositivos Relacionados (Código: MAX)

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Fonte oficial

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