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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 K141417
Device Name CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
1023 CHERRY ROAD
MEMPHIS,  TN  38117
Applicant Contact LESLIE FITCH
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
1023 CHERRY ROAD
MEMPHIS,  TN  38117
Correspondent Contact LESLIE FITCH
Regulation Number888.3030
Classification Product Code
HRS  
Date Received05/29/2014
Decision Date 07/09/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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