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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K040284
Device Name SUSTAIN RADIOLUCENT SPACER
Applicant
Globus Medical, Inc.
303 Schell Ln.
Phoenixville,  PA  19460
Applicant Contact KELLY J BAKER
Correspondent
Globus Medical, Inc.
303 Schell Ln.
Phoenixville,  PA  19460
Correspondent Contact KELLY J BAKER
Regulation Number888.3060
Classification Product Code
MQP  
Date Received02/06/2004
Decision Date 03/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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