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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name posterior metal/polymer spinal system, fusion
510(k) Number K073439
Device Name TRANSITION STABILIZATION SYSTEM
Applicant
GLOBUS MEDICAL INC.
2560 GENERAL ARMISTEAD AVE.
AUDUBON,  PA  19403
Applicant Contact KELLY J BAKER
Correspondent
GLOBUS MEDICAL INC.
2560 GENERAL ARMISTEAD AVE.
AUDUBON,  PA  19403
Correspondent Contact KELLY J BAKER
Regulation Number888.3070
Classification Product Code
NQP  
Date Received12/07/2007
Decision Date 02/20/2009
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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