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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 K073432
Device Name TRAUSON BONE PLATE
Applicant
Trauson (Jiangsu) Medical Instrument Co., Ltd.
Ln. 999, Zhongshan # 2 Rd.
Suite 8d, # 19
Shanghai,  CN 200030
Applicant Contact Diana Hong
Correspondent
Trauson (Jiangsu) Medical Instrument Co., Ltd.
Ln. 999, Zhongshan # 2 Rd.
Suite 8d, # 19
Shanghai,  CN 200030
Correspondent Contact Diana Hong
Regulation Number888.3030
Classification Product Code
HRS  
Date Received12/06/2007
Decision Date 08/13/2008
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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