FORTRESS PEDICLE SCREW SYSTEM

Thoracolumbosacral Pedicle Screw System

SPINEOLOGY, INC.

The following data is part of a premarket notification filed by Spineology, Inc. with the FDA for Fortress Pedicle Screw System.

Pre-market Notification Details

Device IDK140010
510k NumberK140010
Device Name:FORTRESS PEDICLE SCREW SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant SPINEOLOGY, INC. 7800 3RD ST NORTH SUITE 600 St. Paul,  MN  55128
ContactKaren Roche
CorrespondentKaren Roche
SPINEOLOGY, INC. 7800 3RD ST NORTH SUITE 600 St. Paul,  MN  55128
Product CodeNKB  
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-01-02
Decision Date2014-04-23
Summary:summary

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