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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 K120854
Device Name SYNTHES VA LCP ANKLE TRAUMA SYSTEM
Applicant
SYNTHES USA
1301 goshen pkwy
west chester,  PA  19380
Contact angela f lassandro
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received03/21/2012
Decision Date 06/18/2012
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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