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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 K163366
Device Name Shanghai Sanyou CARMEN Cervical Fusion System
Applicant
Shanghai Sanyou Medical Co, Ltd.
1988 Jiatang Rd.
Jiading District,  CN 201807
Applicant Contact David Fan
Correspondent
Mrc-X, LLC
6075 Poplar Ave., Suite 500
Memphis,  TN  38119
Correspondent Contact Christine Scifert
Regulation Number888.3060
Classification Product Code
KWQ  
Subsequent Product Code
ODP  
Date Received11/30/2016
Decision Date 10/05/2017
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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