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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 K172267
Device Name IRENE Thoracolumbar Fixation System
Applicant
Tianjin Zhengtian Medical Instrument Co.,Ltd.
No. 318, Jingyi Road, Airport Economic Zone
Tianjin,  CN 300308
Applicant Contact Ou Changli
Correspondent
Tianjin Zhengtian Medical Instrument Co.,Ltd.
No. 318, Jingyi Road, Airport Economic Zone
Tianjin,  CN 300308
Correspondent Contact Changli Ou
Regulation Number888.3070
Classification Product Code
NKB  
Date Received07/27/2017
Decision Date 03/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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