EXPEDIUM MIS 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 Mis Spine System.

Pre-market Notification Details

Device IDK041801
510k NumberK041801
Device Name:EXPEDIUM MIS SPINE SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
ContactJennifer Mooney
CorrespondentJennifer Mooney
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-07-02
Decision Date2004-09-08
Summary:summary

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