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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
Applicant
Medtronic Sofamor Danek, Inc.
1800 Pyramid Place
Memphis,  TN  38132
Applicant Contact KELLY ANGLIN
Correspondent
Medtronic Sofamor Danek, Inc.
1800 Pyramid Place
Memphis,  TN  38132
Correspondent 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 (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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