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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 K130402
Device Name SPIDER SYSTEM KOLIBRI CEMENT NEEDLE
Applicant
SINTEA PLUSTEK, LLC
13540 GUILD AVE
APPLE VALLEY,  MN  55124
Applicant Contact RICH JANSEN
Correspondent
SINTEA PLUSTEK, LLC
13540 GUILD AVE
APPLE VALLEY,  MN  55124
Correspondent Contact RICH JANSEN
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Code
HXG  
Date Received02/19/2013
Decision Date 04/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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