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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 K092610
Device Name MODIFICATION TO BEACON STABILIZATION 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
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received08/25/2009
Decision Date 09/24/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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