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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, Lumbar
510(k) Number K242267
Device Name Gemini Medical Cage System
Applicant
ZheJiang Decans Medical Devices Co., Ltd.
#2836 Xincheng Ave., Gaozhao St.
Xiuzhou District
Jiaxing,  CN 314031
Applicant Contact Haifeng Liu
Correspondent
Sinow Medical AS
Vestre Fantoftåsen 44, 5072
Bergen,  NO
Correspondent Contact Xiaoqing Xue
Regulation Number888.3080
Classification Product Code
MAX  
Date Received08/01/2024
Decision Date 10/08/2024
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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