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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cement, bone, vertebroplasty
510(k) Number K113742
Device Name KMC KYPHOPLASTY SYSTEM
Original Applicant
SHANGHAI KINETIC MEDICAL CO., LTD
3924cascade beach road
lutsen,  MN  55612
Original Contact gregory mathison
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Code
HRX  
Date Received12/20/2011
Decision Date 09/17/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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