FDA 510(k)

ostaPek Interbody Fusion Cages

Número K: K181963 · 2018-11-14

Data da decisão2018-11-14

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ostaPek Interbody Fusion Cages is the device name listed in this FDA 510(k) record. The listed applicant is Coligne AG. It received FDA 510(k) clearance on 2018-11-14 under 510(k) number K181963. 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 ostaPek Interbody Fusion Cages?

ostaPek Interbody Fusion Cages is a medical device that received FDA 510(k) clearance on 2018-11-14. The listed applicant is Coligne AG. The 510(k) number is K181963.

When did ostaPek Interbody Fusion Cages receive FDA 510(k) clearance?

ostaPek Interbody Fusion Cages received FDA 510(k) clearance on 2018-11-14, under 510(k) number K181963.

Who is the listed applicant for ostaPek Interbody Fusion Cages?

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

What is the FDA product code for ostaPek Interbody Fusion Cages?

The FDA product code for ostaPek Interbody Fusion Cages is MAX.

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Dispositivos Relacionados (Código: MAX)

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Fonte oficial

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