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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