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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, Calcium Compound
510(k) Number K082918
Device Name MASTERGRAFT RESORBABLE CERAMIC GRANULES
Applicant
Medtronic Sofamor Danek
1800 Pyramid Place
Memphis,  TN  38132 -3576
Applicant Contact RYAN MASSEY
Correspondent
Medtronic Sofamor Danek
1800 Pyramid Place
Memphis,  TN  38132 -3576
Correspondent Contact RYAN MASSEY
Regulation Number888.3045
Classification Product Code
MQV  
Date Received09/30/2008
Decision Date 02/09/2009
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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