FDA 510(k) Application Details - K152755

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

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510(K) Number K152755
Device Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant Zimmer, Inc.
345 East Main Street
Warsaw, IN 46580 US
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Contact Dorothy Snyder
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Regulation Number 888.3030

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Classification Product Code KTT
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Date Received 09/24/2015
Decision Date 12/21/2015
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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