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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Integrated Fixation, Cervical
510(k) Number K252774
Device Name Uni-C Cervical Cage System
Applicant
ZheJiang Decans Medical Devices Co., Ltd.
#2836 Xincheng Ave., Gaozhao St., Xiuzhou District
Zhejiang Province
Jiaxing City,  CN 314031
Applicant Contact Haifeng Liu
Correspondent
ZheJiang Decans Medical Devices Co., Ltd.
#2836 Xincheng Ave., Gaozhao St., Xiuzhou District
Zhejiang Province
Jiaxing City,  CN 314031
Correspondent Contact Haifeng Liu
Regulation Number888.3080
Classification Product Code
OVE  
Date Received09/02/2025
Decision Date 04/15/2026
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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