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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name screw, fixation, bone
510(k) Number K140952
Device Name CHARLOTTE CAROLINA JONES FRACTURE SYSTEM 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 Number888.3040
Classification Product Code
HWC  
Date Received04/14/2014
Decision Date 05/15/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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