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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K092146
Device Name XTEND ANTERIOR CERVICAL PLATE 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 Number888.3060
Classification Product Code
KWQ  
Date Received07/15/2009
Decision Date 11/16/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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