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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name appliance, fixation, nail/blade/plate combination, multiple component
510(k) Number K122455
Device Name SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM
Original Applicant
SYNTHES
1301 goshen parkway
west chester,  PA  19380
Original Contact angela f lassandro
Regulation Number888.3030
Classification Product Code
KTT  
Date Received08/13/2012
Decision Date 04/11/2013
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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