SOLANAS AVALON POSTERIOR FIXATION 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 Solanas Avalon Posterior Fixation System.

Pre-market Notification Details

Device IDK111076
510k NumberK111076
Device Name:SOLANAS AVALON POSTERIOR FIXATION SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad,  CA  92008
ContactKarla Schaffner
CorrespondentKarla Schaffner
ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad,  CA  92008
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-04-18
Decision Date2011-07-12
Summary:summary

NIH GUDID Devices

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