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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K252542
Device Name LEO Spinal System
Applicant
ZheJiang Decans Medical Devices Co., Ltd.
#2836 Xincheng Ave., Gaozhao St., Xiuzhou District
Jiaxing City,  CN 314031
Applicant Contact Haifeng Liu
Correspondent
Sinow Medical AS
Vestre Fantoftåsen 44
Bergen,  NO 5072
Correspondent Contact Xiaoqing Xue
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Code
KWP  
Date Received08/12/2025
Decision Date 04/29/2026
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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