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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K152022
Device Name SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIF
Applicant
GLOBUS MEDICAL INC.
VALLEY FORGE BUSINESS CENTER
2560 GENERAL ARMISTEAD AVE.
AUDUBON,  PA  19403
Applicant Contact KELLY J. BAKER
Correspondent
GLOBUS MEDICAL INC.
VALLEY FORGE BUSINESS CENTER
2560 GENERAL ARMISTEAD AVE.
AUDUBON,  PA  19403
Correspondent Contact KELLY J. BAKER
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Codes
MQP   ODP   OVD   OVE  
Date Received07/21/2015
Decision Date 02/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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