FDA 510(k)

Cogent Lateral Interbody System

Número K: K151406 · 2016-02-25

Data da decisão2016-02-25

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Cogent Lateral Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Cogent Spine, LLC. It received FDA 510(k) clearance on 2016-02-25 under 510(k) number K151406. 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 Cogent Lateral Interbody System?

Cogent Lateral Interbody System is a medical device that received FDA 510(k) clearance on 2016-02-25. The listed applicant is Cogent Spine, LLC. The 510(k) number is K151406.

When did Cogent Lateral Interbody System receive FDA 510(k) clearance?

Cogent Lateral Interbody System received FDA 510(k) clearance on 2016-02-25, under 510(k) number K151406.

Who is the listed applicant for Cogent Lateral Interbody System?

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

What is the FDA product code for Cogent Lateral Interbody System?

The FDA product code for Cogent Lateral Interbody System is MAX.

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Dispositivos Relacionados (Código: MAX)

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