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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
Applicant
SYNTHES
1301 goshen parkway
west chester,  PA  19380
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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