INERTIA CONNEXX Modular Pedicle Screw 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 Connexx Modular Pedicle Screw System.

Pre-market Notification Details

Device IDK221905
510k NumberK221905
Device Name:INERTIA CONNEXX Modular Pedicle Screw System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Nexxt Spine LLC 14425 Bergen Blvd Suite B Noblesville,  IN  46060
ContactAndy Elsbury
CorrespondentKaren E Warden
BackRoads Consulting Inc. PO Box 566 Chesterland,  OH  44026
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-30
Decision Date2022-07-28

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