Nano FortiFix® System

Thoracolumbosacral Pedicle Screw System

Nanovis Spine LLC

The following data is part of a premarket notification filed by Nanovis Spine Llc with the FDA for Nano Fortifix® System.

Pre-market Notification Details

Device IDK193211
510k NumberK193211
Device Name:Nano FortiFix® System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Nanovis Spine LLC 5865 East State Rd. 14 Columbia City,  IN  46725
ContactMatthew Hedrick
CorrespondentKaren E Warden
BackRoads Consulting Inc. PO Box 566 Chesterland,  OH  44026
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-21
Decision Date2020-03-20

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