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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 K133715
FOIA Releasable 510(k) K133715
Device Name CHARLOTTE CLAW PLATE SYSTEM
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON,  TN  38002
Applicant Contact LESLIE FITCH
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON,  TN  38002
Correspondent Contact LESLIE FITCH
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received12/05/2013
Decision Date 02/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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