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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name filler, bone void, calcium compound
510(k) Number K130392
Device Name KINEX BIOACTIVE
Applicant
GLOBUS MEDICAL INC.
2560 GENERAL ARMISTEAD AVE.
AUDUBON,  PA  19403
Applicant Contact SARAH MARIE FITZGERALD
Correspondent
GLOBUS MEDICAL INC.
2560 GENERAL ARMISTEAD AVE.
AUDUBON,  PA  19403
Correspondent Contact SARAH MARIE FITZGERALD
Regulation Number888.3045
Classification Product Code
MQV  
Date Received02/15/2013
Decision Date 08/15/2013
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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