FDA 510(k)

Nanovis Intervertebral Body Fusion System and FortiCore®

Número K: K160874 · 2016-06-28

Data da decisão2016-06-28

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Nanovis Intervertebral Body Fusion System and FortiCore® is the device name listed in this FDA 510(k) record. The listed applicant is Nanovis, LLC. It received FDA 510(k) clearance on 2016-06-28 under 510(k) number K160874. 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 Nanovis Intervertebral Body Fusion System and FortiCore®?

Nanovis Intervertebral Body Fusion System and FortiCore® is a medical device that received FDA 510(k) clearance on 2016-06-28. The listed applicant is Nanovis, LLC. The 510(k) number is K160874.

When did Nanovis Intervertebral Body Fusion System and FortiCore® receive FDA 510(k) clearance?

Nanovis Intervertebral Body Fusion System and FortiCore® received FDA 510(k) clearance on 2016-06-28, under 510(k) number K160874.

Who is the listed applicant for Nanovis Intervertebral Body Fusion System and FortiCore®?

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

What is the FDA product code for Nanovis Intervertebral Body Fusion System and FortiCore®?

The FDA product code for Nanovis Intervertebral Body Fusion System and FortiCore® is MAX.

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Fonte oficial

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