Nexxt Matrixx System

Intervertebral Fusion Device With Bone Graft, Lumbar

Nexxt Spine LLC

The following data is part of a premarket notification filed by Nexxt Spine Llc with the FDA for Nexxt Matrixx System.

Pre-market Notification Details

Device IDK193370
510k NumberK193370
Device Name:Nexxt Matrixx System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
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
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-05
Decision Date2020-01-21

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