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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 K161151
Device Name Spinal fixation system
Applicant
Canwell Medical Co., Ltd.
# 466 S. Xianhua St.,High-Tech Industrail Zone
Jinhua,  CN 321016
Applicant Contact CHEN HUI
Correspondent
Osmunda Medical Device Service Group
Level 7, Jin Gui Business Center, 982 Congyun Rd.
Baiyun District
Guangzhou,  CN 510420
Correspondent Contact MIKE GU
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   MNI  
Date Received04/25/2016
Decision Date 09/21/2016
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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