ALLEZ SPINE CROSS CONNECTORS

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 Allez Spine Cross Connectors.

Pre-market Notification Details

Device IDK070460
510k NumberK070460
Device Name:ALLEZ SPINE CROSS CONNECTORS
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 CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-02-16
Decision Date2007-06-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00844856074279 K070460 000
00844856074262 K070460 000
00844856074255 K070460 000

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