FDA 510(k) Application Details - K982390

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

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510(K) Number K982390
Device Name Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Applicant WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON, TN 38002 US
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Contact LYNNE WITKOWSKI
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Regulation Number 888.3030

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Classification Product Code KTW
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Date Received 07/09/1998
Decision Date 09/14/1998
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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