COALITION SPACER

Intervertebral Fusion Device With Integrated Fixation, Cervical

GLOBUS MEDICAL INC.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Coalition Spacer.

Pre-market Notification Details

Device IDK083389
510k NumberK083389
Device Name:COALITION SPACER
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
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 CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-11-17
Decision Date2009-03-26
Summary:summary

NIH GUDID Devices

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