FDA 510(k)

Cascadia Interbody System

Número K: K172009 · 2017-12-14

Data da decisão2017-12-14

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Cascadia Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2017-12-14 under 510(k) number K172009. 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 Cascadia Interbody System?

Cascadia Interbody System is a medical device that received FDA 510(k) clearance on 2017-12-14. The listed applicant is K2m, Inc.. The 510(k) number is K172009.

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

Cascadia Interbody System received FDA 510(k) clearance on 2017-12-14, under 510(k) number K172009.

Who is the listed applicant for Cascadia Interbody System?

The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cascadia Interbody System?

The FDA product code for Cascadia Interbody System is MAX.

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Fonte oficial

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