EXPEDIUM SPINE SYSTEM

Thoracolumbosacral Pedicle Screw System

DEPUY SPINE, INC.

The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Expedium Spine System.

Pre-market Notification Details

Device IDK073126
510k NumberK073126
Device Name:EXPEDIUM SPINE SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
ContactChristopher Klaczyk
CorrespondentChristopher Klaczyk
DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-11-06
Decision Date2007-12-06
Summary:summary

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