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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thoracolumbosacral pedicle screw system
510(k) Number K042953
Device Name MODIFICATION TO PROTEX STABILIZATION SYSTEM
Applicant
GLOBUS MEDICAL, INC.
303 SCHELL LANE
phoenixville,  PA  19460
Applicant Contact kelly j baker
Correspondent
GLOBUS MEDICAL, INC.
303 SCHELL LANE
phoenixville,  PA  19460
Correspondent Contact kelly j baker
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received10/26/2004
Decision Date 11/22/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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