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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K143013
Device Name Spinal Inner Fixation System
Applicant
Changzhou Dingjian Medical Appliance Co., Ltd.
#19 Juxiang Rd., Wujin Economic Development Zone
Changzhou,  CN 213149
Applicant Contact Li Quinsong
Correspondent
Osmunda Medical Device Consulting Co., Ltd.
7th Floor, Jingui Business Bldg., 982 Cogyun Rd.
Baiyun District
Guangzhou,  CN 510420
Correspondent Contact MIKE GU
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   MNI  
Date Received10/20/2014
Decision Date 12/11/2015
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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