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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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