Syntec Femoral Nail Extended System

Rod, Fixation, Intramedullary And Accessories

Syntee Scientific Corporation

The following data is part of a premarket notification filed by Syntee Scientific Corporation with the FDA for Syntec Femoral Nail Extended System.

Pre-market Notification Details

Device IDK202935
510k NumberK202935
Device Name:Syntec Femoral Nail Extended System
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant Syntee Scientific Corporation No.2, Kung San Road Chuan Shing Industrial Zone, Shen Kang Chang Hua,  TW 50971
ContactNicole Tseng
CorrespondentNicole Tseng
Syntec Scientific Corporation - Taipei Office 3f ., No.96, Sec. 3, Zhongxio East Road Da'An Dist., Taipei,  TW 10652
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-29
Decision Date2020-10-28

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