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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 K121601
Device Name SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE
Original Applicant
SYNTHES USA
1301 goshen pkwy
west chester,  PA  19380
Original Contact angela f lassandro
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received06/01/2012
Decision Date 07/06/2012
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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