FDA 510(k)

Velofix TLIF Cage

Número K: K183243 · 2019-07-10

Data da decisão2019-07-10

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Velofix TLIF Cage 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 2019-07-10 under 510(k) number K183243. 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 Velofix TLIF Cage?

Velofix TLIF Cage is a medical device that received FDA 510(k) clearance on 2019-07-10. The listed applicant is U&I Corporation. The 510(k) number is K183243.

When did Velofix TLIF Cage receive FDA 510(k) clearance?

Velofix TLIF Cage received FDA 510(k) clearance on 2019-07-10, under 510(k) number K183243.

Who is the listed applicant for Velofix TLIF Cage?

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 TLIF Cage?

The FDA product code for Velofix TLIF Cage is MAX.

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Fonte oficial

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