Expedium Spine System, VIPER And VIPER 2 Systems

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, Viper And Viper 2 Systems.

Pre-market Notification Details

Device IDK160904
510k NumberK160904
Device Name:Expedium Spine System, VIPER And VIPER 2 Systems
ClassificationThoracolumbosacral Pedicle Screw System
Applicant MEDOS INTERNATIONAL SARL CHEMIN-BLANC 38 Le Locle,  CH 2400
ContactKaren Sylvia
CorrespondentMitch Ohiwa
DEPUY SYNTHES SPINE 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 Received2016-04-01
Decision Date2016-07-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10705034537368 K160904 000
10705034537351 K160904 000

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