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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 K122210
Device Name NEWFIX EXTERNAL FIXATION SYSTEM
Original Applicant
TECNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V
po box 506
south lyon,  MI  48178
Original Contact robert j bard
Regulation Number888.3030
Classification Product Code
KTT  
Date Received07/25/2012
Decision Date 04/19/2013
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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