FDA 510(k) Application Details - K141912

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

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510(K) Number K141912
Device Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
3203 KASHIWA STREET
TORRANCE, CA 90505 US
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Contact ANNA HWANG
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Regulation Number 888.3030

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Classification Product Code KTT
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Date Received 07/15/2014
Decision Date 10/29/2014
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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