FDA 510(k) Application Details - K132704

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

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510(K) Number K132704
Device Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Applicant BIOMET
56 EAST BELL DR.
P.O BOX 587
WARSAW, IN 46581-0587 US
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Contact SUZANA OTANO
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Regulation Number 888.3030

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Classification Product Code LXT
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Date Received 08/29/2013
Decision Date 10/09/2013
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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