EXPEDIUM SPINE SYSTEM

Thoracolumbosacral Pedicle Screw System

MEDOS INTERNATIONAL SARL

The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Expedium Spine System.

Pre-market Notification Details

Device IDK130877
510k NumberK130877
Device Name:EXPEDIUM SPINE SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant MEDOS INTERNATIONAL SARL 325 Paramount Drive Raynham,  MA  02767
ContactKirsten Lehmuller
CorrespondentKirsten Lehmuller
MEDOS INTERNATIONAL SARL 325 Paramount Drive Raynham,  MA  02767
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
Subsequent Product CodeOSH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-29
Decision Date2013-06-20
Summary:summary

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