FDA 510(k)

Idys ALIF 3DTi

Número K: K200919 · 2021-04-12

Data da decisão2021-04-12

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Idys ALIF 3DTi is the device name listed in this FDA 510(k) record. The listed applicant is Clariance. It received FDA 510(k) clearance on 2021-04-12 under 510(k) number K200919. 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 ALIF 3DTi?

Idys ALIF 3DTi is a medical device that received FDA 510(k) clearance on 2021-04-12. The listed applicant is Clariance. The 510(k) number is K200919.

When did Idys ALIF 3DTi receive FDA 510(k) clearance?

Idys ALIF 3DTi received FDA 510(k) clearance on 2021-04-12, under 510(k) number K200919.

Who is the listed applicant for Idys ALIF 3DTi?

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

What is the FDA product code for Idys ALIF 3DTi?

The FDA product code for Idys ALIF 3DTi is MAX.

Outros registros que listam Clariance como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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Fonte oficial

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