PATRIOT SPACERS

Intervertebral Fusion Device With Bone Graft, Lumbar

GLOBUS MEDICAL, INC.

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

Pre-market Notification Details

Device IDK072970
510k NumberK072970
Device Name:PATRIOT SPACERS
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER Audubon,  PA  19403
ContactKelly J Baker
CorrespondentKelly J Baker
GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER Audubon,  PA  19403
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-22
Decision Date2008-01-18
Summary:summary

NIH GUDID Devices

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