FDA 510(k)

Velofix Interbody Fusion System

Número K: K190067 · 2019-02-04

Data da decisão2019-02-04

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Velofix Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is U&I Corporation. It received FDA 510(k) clearance on 2019-02-04 under 510(k) number K190067. 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 Velofix Interbody Fusion System?

Velofix Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2019-02-04. The listed applicant is U&I Corporation. The 510(k) number is K190067.

When did Velofix Interbody Fusion System receive FDA 510(k) clearance?

Velofix Interbody Fusion System received FDA 510(k) clearance on 2019-02-04, under 510(k) number K190067.

Who is the listed applicant for Velofix Interbody Fusion System?

The FDA 510(k) record lists U&I Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Velofix Interbody Fusion System?

The FDA product code for Velofix Interbody Fusion System is ODP.

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Dispositivos Relacionados (Código: ODP)

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Fonte oficial

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