FORTIFY Corpectomy Spacers

Spinal Vertebral Body Replacement Device

GLOBUS MEDICAL INC.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Fortify Corpectomy Spacers.

Pre-market Notification Details

Device IDK162315
510k NumberK162315
Device Name:FORTIFY Corpectomy Spacers
ClassificationSpinal Vertebral Body Replacement 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 CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-18
Decision Date2017-11-09
Summary:summary

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