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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 K140792
Device Name SALVATION 3DI PLATING SYSTEM
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 Received03/31/2014
Decision Date 05/22/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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