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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 K082166
Device Name MASTERGRAFT STRIP
Applicant
Medtronic Sofamor Danek
1800 Pyramid Pl.
Memphis,  TN  38132
Applicant Contact MICHELLE OBENAUER
Correspondent
Medtronic Sofamor Danek
1800 Pyramid Pl.
Memphis,  TN  38132
Correspondent Contact MICHELLE OBENAUER
Regulation Number888.3045
Classification Product Code
MQV  
Date Received07/31/2008
Decision Date 06/02/2009
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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