TranS1 AxiaLIF Plus System

Appliance, Fixation, Spinal Intervertebral Body

TranS1

The following data is part of a premarket notification filed by Trans1 with the FDA for Trans1 Axialif Plus System.

Pre-market Notification Details

Device IDK192792
501k NumberK192792
Device Name:TranS1 AxiaLIF Plus System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant TranS1 3804 Park Avenue Wilmington,  NC  28403
ContactKristen Allen
CorrespondentKristen Allen
TranS1 3804 Park Avenue Wilmington,  NC  28403
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-30
Decision Date2019-11-20

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