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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 K031302
Device Name SUSTAIN SPACER
Applicant
Globus Medical, Inc.
303 Schell Ln.
Phoenixville,  PA  19460
Applicant Contact DANIEL S PAUL
Correspondent
Globus Medical, Inc.
303 Schell Ln.
Phoenixville,  PA  19460
Correspondent Contact DANIEL S PAUL
Regulation Number888.3060
Classification Product Code
MQP  
Date Received04/24/2003
Decision Date 06/27/2003
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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