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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 K070082
Device Name XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY
Applicant
Vertebration,Inc
310 Ter. Ave.
Suite 201
Cincinnati,  OH  45220
Applicant Contact BARBARA S FANT, PHARM.D.
Correspondent
Vertebration,Inc
310 Ter. Ave.
Suite 201
Cincinnati,  OH  45220
Correspondent Contact BARBARA S FANT, PHARM.D.
Regulation Number888.3060
Classification Product Code
MQP  
Date Received01/09/2007
Decision Date 04/20/2007
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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