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FDA 510(k) Application Details - K143220
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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510(K) Number
K143220
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
1023 Cherry Road
Memphis, TN 38117 US
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Contact
Leslie Fitch
Other 510(k) Applications for this Contact
Regulation Number
888.3030
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Classification Product Code
KTT
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More FDA Info for this Product Code
Date Received
11/10/2014
Decision Date
01/08/2015
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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