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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
Applicant
SYNTHES (USA) PRODUCTS LLC
1230 Wilson Dr
West Chester,  PA  19380
Applicant Contact THOMAS N SHEA
Correspondent
SYNTHES (USA) PRODUCTS LLC
1230 Wilson Dr
West Chester,  PA  19380
Correspondent 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 (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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