LAGUNA SIZE 8 PEDICLE SCREW

Thoracolumbosacral Pedicle Screw System

ALLEZ SPINE, LLC

The following data is part of a premarket notification filed by Allez Spine, Llc with the FDA for Laguna Size 8 Pedicle Screw.

Pre-market Notification Details

Device IDK072678
510k NumberK072678
Device Name:LAGUNA SIZE 8 PEDICLE SCREW
ClassificationThoracolumbosacral Pedicle Screw System
Applicant ALLEZ SPINE, LLC 2301 DUPONT DRIVE, SUITE 510 Irvine,  CA  92612
ContactHartmut Loch
CorrespondentHartmut Loch
ALLEZ SPINE, LLC 2301 DUPONT DRIVE, SUITE 510 Irvine,  CA  92612
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-21
Decision Date2008-07-02
Summary:summary

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