Inertia Pedicle Screw And Deformity Correxxion System

Thoracolumbosacral Pedicle Screw System

NEXXT SPINE LLC

The following data is part of a premarket notification filed by Nexxt Spine Llc with the FDA for Inertia Pedicle Screw And Deformity Correxxion System.

Pre-market Notification Details

Device IDK153453
510k NumberK153453
Device Name:Inertia Pedicle Screw And Deformity Correxxion System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant NEXXT SPINE LLC 14425 BERGEN BLVD, SUITE B Noblesville,  IN  46060
ContactAndy Elsbury
CorrespondentKaren E. Warden
BACKROADS CONSULTING PO BOX 566 Chesterland,  OH  44026 -2141
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeMNH
Subsequent Product CodeMNI
Subsequent Product CodeOSH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-30
Decision Date2016-04-26
Summary:summary

NIH GUDID Devices

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