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FDA 510(k) Applications Submitted by Pamela Edwards
FDA 510(k) Number
Submission Date
Device Name
Applicant
K160983
04/07/2016
Kyphon HV-R Bone Cement
MEDTRONIC INC
K151532
06/08/2015
KYPHON ELEMENT Inflatable Bone Tamp
MEDTRONIC, INC.
K092087
07/09/2009
MEDTRONIC DENTAL TCP
MEDTRONIC SOFAMOR DANEK USA, INC.
K152604
09/11/2015
KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set
Medtronic Sofamor Danek USA, Incorporated
K163032
10/31/2016
Kyphon Xpede Bone Cement
Medtronic Inc.
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