FDA 510(k) Application Details - K113106

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

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510(K) Number K113106
Device Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant D.N.E., LLC
1001 OAKWOOD BLVD
ROUND ROCK, TX 78681 US
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Contact J.D. WEBB
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Regulation Number 888.3030

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Classification Product Code KTT
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Date Received 10/20/2011
Decision Date 01/04/2012
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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