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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Cervical Screw System
510(k) Number K253195
Device Name TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems
Applicant
ZheJiang Decans Medical Devices Co., Ltd.
#2836,Xincheng Ave.,Gaozhao St.,Xiuzhou District
Jiaxing City, Zhejiang Province,314031,P.R. China
Jiaxing,  CN Zhejiang
Applicant Contact Haifeng Liu
Correspondent
ZheJiang Decans Medical Devices Co., Ltd.
#2836,Xincheng Ave.,Gaozhao St.,Xiuzhou District
Jiaxing City, Zhejiang Province,314031,P.R. China
Jiaxing,  CN Zhejiang
Correspondent Contact Haifeng Liu
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received09/26/2025
Decision Date 06/02/2026
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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