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

Posterior Cervical Screw System

Globus Medical Inc.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Quartex Occipito-cervico-thoracic Spinal System, Globus Navigation Instruments.

Pre-market Notification Details

Device IDK211957
510k NumberK211957
Device Name:QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
ClassificationPosterior Cervical Screw System
Applicant Globus Medical Inc. 2560 General Armistead Ave. Audubon,  PA  19403
ContactJennifer Antonacci
CorrespondentJennifer Antonacci
Globus Medical Inc. 2560 General Armistead Ave. Audubon,  PA  19403
Product CodeNKG  
Subsequent Product CodeKWP
Subsequent Product CodeOLO
CFR Regulation Number888.3075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-24
Decision Date2021-08-18

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.