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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name filler, bone void, osteoinduction (w/o human growth factor)
510(k) Number K122513
Device Name CLEARED UNDER GRAFTON II EDBM
Original Applicant
MEDTRONIC SOFAMOR DANEK, INC.
1800 pyramid place
memphis,  TN  38132
Original Contact kelly anglin
Regulation Number888.3045
Classification Product Code
MBP  
Subsequent Product Code
MQV  
Date Received08/17/2012
Decision Date 03/06/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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