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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 K172828
Device Name Double Medical Cage System
Applicant
Double Medical Technology, Inc.
# 18, Shanbianhong E. Rd., Haicang District
Xiamen,  CN 361026
Applicant Contact Yan Zuo
Correspondent
Double Medical Technology, Inc.
# 18, Shanbianhong E. Rd., Haicang District
Xiamen,  CN 361026
Correspondent Contact Yan Zuo
Regulation Number888.3080
Classification Product Code
MAX  
Date Received09/18/2017
Decision Date 02/01/2018
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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