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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K191617
Device Name Syntec Tibial Nail System
Applicant
Syntec Scientific Corporation
#2, Kung San Rd. Chuan Shing Industrial Zone, Shen Kang
Chang Hua,  TW 50971
Applicant Contact Kavin Chu
Correspondent
Syntec Scientific Corporation - Taipei Office
3f., # 96, Sec. 3, Zhongxio E. Rd. Da'An Dist.
Taipei,  TW 10652
Correspondent Contact Kavin Chu
Regulation Number888.3020
Classification Product Code
HSB  
Date Received06/18/2019
Decision Date 09/03/2019
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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