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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, fixation, bone
510(k) Number K150520
Device Name DARCO Locking Bone Plate System
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
1023 Cherry Road
Memphis,  TN  38117
Applicant Contact JEANINE REDDEN
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
1023 Cherry Road
Memphis,  TN  38117
Correspondent Contact JEANINE REDDEN
Regulation Number888.3030
Classification Product Code
HRS  
Date Received03/02/2015
Decision Date 04/29/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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