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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K132078
Device Name METALLIC INTRAMEDULLARY NAIL SYSTEM
Applicant
Tianjin Walkman Biomaterial Co., Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Applicant Contact Diana Hong
Correspondent
Tianjin Walkman Biomaterial Co., Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number888.3020
Classification Product Code
HSB  
Date Received07/05/2013
Decision Date 03/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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