MODIFICATIONS TO 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 Modifications To Expedium Spine System.

Pre-market Notification Details

Device IDK082195
510k NumberK082195
Device Name:MODIFICATIONS TO EXPEDIUM SPINE SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
ContactFrank Jurczak
CorrespondentFrank Jurczak
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 Received2008-08-04
Decision Date2008-09-03
Summary:summary

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