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 IDK092473
510k NumberK092473
Device Name:EXPEDIUM SPINE SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant DEPUY SPINE,INC 325 PARAMONT DRIVE Raynham,  MA  02767
ContactLisa Gilman
CorrespondentLisa Gilman
DEPUY SPINE,INC 325 PARAMONT DRIVE 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 Received2009-08-12
Decision Date2009-11-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10705034115764 K092473 000
10705034108483 K092473 000

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