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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 Bone Graft, Cervical
510(k) Number K242195
Device Name Gemini Cervical Fusion Cage System
Applicant
ZheJiang Decans Medical Devices Co., Ltd.
#2836 Xincheng Ave., Gaozhao St.
Xiuzhou District
Jiaxing,  CN 314031
Applicant Contact Chen Liu
Correspondent
ZheJiang Decans Medical Devices Co., Ltd.
#2836 Xincheng Ave., Gaozhao St.
Xiuzhou District
Jiaxing,  CN 314031
Correspondent Contact Chen Liu
Regulation Number888.3080
Classification Product Code
ODP  
Date Received07/26/2024
Decision Date 11/04/2024
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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