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 IDK132866
510k NumberK132866
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-13
Decision Date2013-10-28
Summary:summary

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