FDA 510(k)

Idys™ TLIF TiVac

Número K: K183259 · 2019-03-01

Data da decisão2019-03-01

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Idys™ TLIF TiVac is the device name listed in this FDA 510(k) record. The listed applicant is Clariance, Sas. It received FDA 510(k) clearance on 2019-03-01 under 510(k) number K183259. 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 Idys™ TLIF TiVac?

Idys™ TLIF TiVac is a medical device that received FDA 510(k) clearance on 2019-03-01. The listed applicant is Clariance, Sas. The 510(k) number is K183259.

When did Idys™ TLIF TiVac receive FDA 510(k) clearance?

Idys™ TLIF TiVac received FDA 510(k) clearance on 2019-03-01, under 510(k) number K183259.

Who is the listed applicant for Idys™ TLIF TiVac?

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

What is the FDA product code for Idys™ TLIF TiVac?

The FDA product code for Idys™ TLIF TiVac is MAX.

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Fonte oficial

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