MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM

Thoracolumbosacral Pedicle Screw System

ALPHATEC SPINE, INC.

The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Modification To Solanas Posterior Stabilization System.

Pre-market Notification Details

Device IDK071380
510k NumberK071380
Device Name:MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant ALPHATEC SPINE, INC. 2051 PALOMAR AIRPORT ROAD SUITE 100 Carlsbad,  CA  92011
ContactPaula Morgan
CorrespondentPaula Morgan
ALPHATEC SPINE, INC. 2051 PALOMAR AIRPORT ROAD SUITE 100 Carlsbad,  CA  92011
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-05-17
Decision Date2007-08-20
Summary:summary

NIH GUDID Devices

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