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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K151532
Device Name KYPHON ELEMENT Inflatable Bone Tamp
Applicant
Medtronic, Inc.
1800 Pyramid Place
Memphis,  TN  38132
Applicant Contact PAMELA EDWARDS
Correspondent
Medtronic, Inc.
1800 Pyramid Place
Memphis,  TN  38132
Correspondent Contact PAMELA EDWARDS
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
HXG  
Date Received06/08/2015
Decision Date 07/23/2015
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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