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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, facet screw spinal device
510(k) Number K090952
Device Name ZYFUSE FACET FIXATION SYSTEM
Applicant
GLOBUS MEDICAL, INC.
2560 GENERAL ARMISTEAD AVE.
VALLEY FORGE BUSINESS CENTER
AUDUBON,  PA  19403
Applicant Contact KELLY J BAKER
Correspondent
GLOBUS MEDICAL, INC.
2560 GENERAL ARMISTEAD AVE.
VALLEY FORGE BUSINESS CENTER
AUDUBON,  PA  19403
Correspondent Contact KELLY J BAKER
Classification Product Code
MRW  
Date Received04/03/2009
Decision Date 07/14/2009
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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