NAUTILUS SPINAL SYSTEM

Thoracolumbosacral Pedicle Screw System

LIFE SPINE, INC

The following data is part of a premarket notification filed by Life Spine, Inc with the FDA for Nautilus Spinal System.

Pre-market Notification Details

Device IDK140457
510k NumberK140457
Device Name:NAUTILUS SPINAL SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant LIFE SPINE, INC 2401 W. HASSELL RD SUITE 1535 Hoffman Estates,  IL  60169
ContactRandy Lewis
CorrespondentRandy Lewis
LIFE SPINE, INC 2401 W. HASSELL RD SUITE 1535 Hoffman Estates,  IL  60169
Product CodeNKB  
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-02-24
Decision Date2014-03-25
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.