FDA 510(k)

AxoGuard Nerve Connector

Número K: K162741 · 2016-10-31

Data da decisão2016-10-31

Código do produtoJXI

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

AxoGuard Nerve Connector is the device name listed in this FDA 510(k) record. The listed applicant is Cook Biotech Incorporated. It received FDA 510(k) clearance on 2016-10-31 under 510(k) number K162741. The device is classified under product code JXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AxoGuard Nerve Connector?

AxoGuard Nerve Connector is a medical device that received FDA 510(k) clearance on 2016-10-31. The listed applicant is Cook Biotech Incorporated. The 510(k) number is K162741.

When did AxoGuard Nerve Connector receive FDA 510(k) clearance?

AxoGuard Nerve Connector received FDA 510(k) clearance on 2016-10-31, under 510(k) number K162741.

Who is the listed applicant for AxoGuard Nerve Connector?

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

What is the FDA product code for AxoGuard Nerve Connector?

The FDA product code for AxoGuard Nerve Connector is JXI.

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Fonte oficial

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