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 Solanas Posterior Stabilization System.

Pre-market Notification Details

Device IDK131119
510k NumberK131119
Device Name:SOLANAS POSTERIOR STABILIZATION SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad,  CA  92008
ContactTrevor Denbo
CorrespondentTrevor Denbo
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-04-22
Decision Date2013-05-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00844856064249 K131119 000
00844856064232 K131119 000

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