FDA 510(k)

Opticage(R) Expandable Interbody Fusion Device

Número K: K160464 · 2016-04-04

Data da decisão2016-04-04

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Opticage(R) Expandable Interbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Interventional Spine, Inc.. It received FDA 510(k) clearance on 2016-04-04 under 510(k) number K160464. 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 Opticage(R) Expandable Interbody Fusion Device?

Opticage(R) Expandable Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2016-04-04. The listed applicant is Interventional Spine, Inc.. The 510(k) number is K160464.

When did Opticage(R) Expandable Interbody Fusion Device receive FDA 510(k) clearance?

Opticage(R) Expandable Interbody Fusion Device received FDA 510(k) clearance on 2016-04-04, under 510(k) number K160464.

Who is the listed applicant for Opticage(R) Expandable Interbody Fusion Device?

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

What is the FDA product code for Opticage(R) Expandable Interbody Fusion Device?

The FDA product code for Opticage(R) Expandable Interbody Fusion Device is MAX.

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