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FDA 510(k) Application Details - K122777
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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510(K) Number
K122777
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant
NUTEK ORTHOPAEDICS, INC.
301 S.W. 7TH ST.
FT. LAUDERDALE, FL 33315 US
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PETER MINCIELI
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Regulation Number
888.3030
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Classification Product Code
KTT
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More FDA Info for this Product Code
Date Received
09/11/2012
Decision Date
05/15/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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