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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 K082466
Device Name XYCOR SPINAL IMPLANT
Applicant
Vertebration,Inc
310 Terrace Ave.
Suite 201
Cincinnati,  OH  45220
Applicant Contact BARBARA FANT
Correspondent
Vertebration,Inc
310 Terrace Ave.
Suite 201
Cincinnati,  OH  45220
Correspondent Contact BARBARA FANT
Regulation Number888.3060
Classification Product Code
MQP  
Date Received08/27/2008
Decision Date 01/09/2009
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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