FDA 510(k)

Peekplus® Interbody Fusion Device

Número K: K173864 · 2018-07-02

Data da decisão2018-07-02

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Peekplus® Interbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Vallum Corporation. It received FDA 510(k) clearance on 2018-07-02 under 510(k) number K173864. 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 Peekplus® Interbody Fusion Device?

Peekplus® Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2018-07-02. The listed applicant is Vallum Corporation. The 510(k) number is K173864.

When did Peekplus® Interbody Fusion Device receive FDA 510(k) clearance?

Peekplus® Interbody Fusion Device received FDA 510(k) clearance on 2018-07-02, under 510(k) number K173864.

Who is the listed applicant for Peekplus® Interbody Fusion Device?

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

What is the FDA product code for Peekplus® Interbody Fusion Device?

The FDA product code for Peekplus® Interbody Fusion Device is MAX.

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