FDA 510(k) Application Details - K960014

Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

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510(K) Number K960014
Device Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant ORTHOPAEDIC INNOVATIONS, INC.
825 SOUTH 8TH ST.
SUITE 700
MINNEAPOLIS, MN 55404 US
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Contact CAROLYN M STEELE
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Regulation Number 888.3030

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Classification Product Code KTT
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Date Received 01/02/1996
Decision Date 03/18/1996
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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