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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spine, Plate, Laminoplasty, Metal
510(k) Number K252930
Device Name AQUA Laminoplasty Systems
Applicant
ZheJiang Decans Medical Devices Co., Ltd.
#2836 Xincheng Ave., Gaozhao St.
Xiuzhou District
Jiaxing,  CN 314031
Applicant Contact Haifeng Liu
Correspondent
ZheJiang Decans Medical Devices Co., Ltd.
#2836 Xincheng Ave., Gaozhao St.
Xiuzhou District
Jiaxing,  CN 314031
Correspondent Contact Haifeng Liu
Regulation Number888.3050
Classification Product Code
NQW  
Date Received09/15/2025
Decision Date 05/27/2026
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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