FDA 510(k)

Idys™ TLIF 3DTi Cages

Número K: K172465 · 2017-12-15

Data da decisão2017-12-15

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Idys™ TLIF 3DTi Cages is the device name listed in this FDA 510(k) record. The listed applicant is Clariance, Sas. It received FDA 510(k) clearance on 2017-12-15 under 510(k) number K172465. 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 3DTi Cages?

Idys™ TLIF 3DTi Cages is a medical device that received FDA 510(k) clearance on 2017-12-15. The listed applicant is Clariance, Sas. The 510(k) number is K172465.

When did Idys™ TLIF 3DTi Cages receive FDA 510(k) clearance?

Idys™ TLIF 3DTi Cages received FDA 510(k) clearance on 2017-12-15, under 510(k) number K172465.

Who is the listed applicant for Idys™ TLIF 3DTi Cages?

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 3DTi Cages?

The FDA product code for Idys™ TLIF 3DTi Cages is MAX.

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Fonte oficial

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