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 IDK131449
510k NumberK131449
Device Name:COALITION SPACER
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant GLOBUS MEDICAL, INC. 2560 General Armistead Ave VALLEY FORGE BUSINESS CENTER Audubon,  PA  19403
ContactChristina Kichula
CorrespondentChristina Kichula
GLOBUS MEDICAL, INC. 2560 General Armistead Ave VALLEY FORGE BUSINESS CENTER Audubon,  PA  19403
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-20
Decision Date2013-07-30
Summary:summary

NIH GUDID Devices

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