CORRIDOR Fixation System

System, Facet Screw Spinal Device

Globus Medical Inc.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Corridor Fixation System.

Pre-market Notification Details

Device IDK192744
510k NumberK192744
Device Name:CORRIDOR Fixation System
ClassificationSystem, Facet Screw Spinal Device
Applicant Globus Medical Inc. 2560 General Armistead Ave. Audubon,  PA  19403
ContactKelly J. Baker
CorrespondentKelly J. Baker
Globus Medical Inc. 2560 General Armistead Ave. Audubon,  PA  19403
Product CodeMRW  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-30
Decision Date2019-12-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.