SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM

Rod, Fixation, Intramedullary And Accessories

SYNTEC SCIENTIFIC CORP.

The following data is part of a premarket notification filed by Syntec Scientific Corp. with the FDA for Syntec-taichung Non-sterile Unreamed Interlocking Nail System.

Pre-market Notification Details

Device IDK984602
510k NumberK984602
Device Name:SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant SYNTEC SCIENTIFIC CORP. 2, KUNG SAN ROAD, CHAUN SHING INDUSTRIAL ZONE, SHEN KANG Chang Hua,  TW 509
ContactTed Y Shi
CorrespondentTed Y Shi
SYNTEC SCIENTIFIC CORP. 2, KUNG SAN ROAD, CHAUN SHING INDUSTRIAL ZONE, SHEN KANG Chang Hua,  TW 509
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-12-28
Decision Date1999-03-05
Summary:summary

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