FDA 510(k)

XCage™ Interbody Fusion System

Número K: K160076 · 2016-10-13

Data da decisão2016-10-13

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

XCage™ Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Ouroboros Medical, Inc.. It received FDA 510(k) clearance on 2016-10-13 under 510(k) number K160076. 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 XCage™ Interbody Fusion System?

XCage™ Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2016-10-13. The listed applicant is Ouroboros Medical, Inc.. The 510(k) number is K160076.

When did XCage™ Interbody Fusion System receive FDA 510(k) clearance?

XCage™ Interbody Fusion System received FDA 510(k) clearance on 2016-10-13, under 510(k) number K160076.

Who is the listed applicant for XCage™ Interbody Fusion System?

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

What is the FDA product code for XCage™ Interbody Fusion System?

The FDA product code for XCage™ Interbody Fusion System is MAX.

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