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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name appliance, fixation, spinal intervertebral body
510(k) Number K223753
Device Name Cervical Plate System
Applicant
Double Medical Technology Inc.
No. 18, Shanbianhong East Road, Haicang District
Xiamen,  CN 361026
Applicant Contact Yan Zuo
Correspondent
Double Medical Technology Inc.
No. 18, Shanbianhong East Road, Haicang District
Xiamen,  CN 361026
Correspondent Contact Yan Zuo
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received12/14/2022
Decision Date 03/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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