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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 K122777
Device Name NBX - NON BRIDGING EXTERNAL FIXATOR HAND
Applicant
NUTEK ORTHOPAEDICS, INC.
301 s.w. 7th st.
ft. lauderdale,  FL  33315
Contact peter mincieli
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Code
JEC  
Date Received09/11/2012
Decision Date 05/15/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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