Syntec Non-Sterile Steinmann Pins System

Pin, Fixation, Threaded

Syntec Scientific Corporation

The following data is part of a premarket notification filed by Syntec Scientific Corporation with the FDA for Syntec Non-sterile Steinmann Pins System.

Pre-market Notification Details

Device IDK200933
510k NumberK200933
Device Name:Syntec Non-Sterile Steinmann Pins System
ClassificationPin, Fixation, Threaded
Applicant Syntec 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 CodeJDW  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-07
Decision Date2020-05-05

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