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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 K073502
Device Name VERTEBRON VBR SYSTEM
Applicant
Vertebron, Inc.
80 Hathaway Dr.
Stratford,  CT  06615
Applicant Contact LUIS NESPRIDO
Correspondent
Vertebron, Inc.
80 Hathaway Dr.
Stratford,  CT  06615
Correspondent Contact LUIS NESPRIDO
Regulation Number888.3060
Classification Product Code
MQP  
Date Received12/13/2007
Decision Date 03/24/2008
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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