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510(k) K122513

CLEARED UNDER GRAFTON II EDBM by Medtronic Sofamor Danek, Inc. — Product Code MBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2013
Date Received
August 17, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type

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