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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 K241073
Device Name DZ-Tabone Intervertebral Body Fusion Device
Applicant
Shenzhen Dazhou Medical Technology Co., Ltd.
Suite B605, Bldg. #1, Yesun Intelligent Community Ll,
1301-76 Guanguang Rd., Longhua District
Shenzhen,  CN 518110
Applicant Contact Jingzhou Yang
Correspondent
Cosmos Biomed Consulting
Rm. 305, #1415, Huashan Rd., Changning District
Shanghai City,  CN
Correspondent Contact Ray Chang
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
ODP  
Date Received04/19/2024
Decision Date 12/06/2024
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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