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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K190567
Device Name KeYi Spinal Fixation System
Applicant
Beijing Keyi Medical Device Technology Co., Ltd.
Bldg. 1, 30 Yongchang S. Rd.
Beijing,  CN 100176
Applicant Contact Jenny Jiang
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number888.3070
Classification Product Code
NKB  
Date Received03/06/2019
Decision Date 05/08/2019
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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