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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 K051815
Device Name MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM
Applicant
Vertebron, Inc.
400 Long Beach Blvd.
Stratford,  CT  06615
Applicant Contact LUIS NESPRIDO
Correspondent
Vertebron, Inc.
400 Long Beach Blvd.
Stratford,  CT  06615
Correspondent Contact LUIS NESPRIDO
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received07/05/2005
Decision Date 10/17/2005
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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