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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Cement, Posterior Screw Augmentation
510(k) Number K152604
Device Name KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set
Applicant
Medtronic Sofamor Danek USA, Incorporated
1800 Pyramid Place
Memphis,  TN  38132
Applicant Contact Pamela Edwards
Correspondent
Medtronic Sofamor Danek USA, Incorporated
1800 Pyramid Place
Memphis,  TN  38132
Correspondent Contact Lee Grant
Regulation Number888.3027
Classification Product Code
PML  
Subsequent Product Code
MNI  
Date Received09/11/2015
Decision Date 01/06/2016
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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