FDA 510(k)

QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments

Numéro K : K161591 · 2016-09-21

Date de décision2016-09-21

Code produitNKG

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2016-09-21 under 510(k) number K161591. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments?

QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments is a medical device that received FDA 510(k) clearance on 2016-09-21. The listed applicant is Globus Medical, Inc.. The 510(k) number is K161591.

When did QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments receive FDA 510(k) clearance?

QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments received FDA 510(k) clearance on 2016-09-21, under 510(k) number K161591.

Who is the listed applicant for QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments?

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

What is the FDA product code for QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments?

The FDA product code for QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments is NKG.

Essais cliniques associés

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Source officielle

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