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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, fixation, bone
510(k) Number K120689
Device Name SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM
Original Applicant
SYNTHES (USA) PRODUCTS LLC
1230 wilson dr
west chester,  PA  19380
Original Contact thomas n shea
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received03/06/2012
Decision Date 06/04/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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