EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System

Thoracolumbosacral Pedicle Screw System

Medos International Sàrl

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

Pre-market Notification Details

Device IDK200245
510k NumberK200245
Device Name:EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Medos International Sàrl Chemin-Blanc 38 Le Locle,  CH 2400
ContactRhoda Maddonni
CorrespondentRhoda Maddonni
DePuy Synthes Spine 325 Paramount Drive Raynham,  MA  02767
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-31
Decision Date2020-04-24

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