FDA 510(k)

XIHPOS™ ZFUZE™ Interbody Fusion System

Número K: K190544 · 2019-11-01

Data da decisão2019-11-01

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

XIHPOS™ ZFUZE™ Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Difusion Technologies. It received FDA 510(k) clearance on 2019-11-01 under 510(k) number K190544. 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 XIHPOS™ ZFUZE™ Interbody Fusion System?

XIHPOS™ ZFUZE™ Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2019-11-01. The listed applicant is Difusion Technologies. The 510(k) number is K190544.

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

XIHPOS™ ZFUZE™ Interbody Fusion System received FDA 510(k) clearance on 2019-11-01, under 510(k) number K190544.

Who is the listed applicant for XIHPOS™ ZFUZE™ Interbody Fusion System?

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

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

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

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