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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-31
Decision Date2020-04-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10705034562704 K200245 000
10705034562698 K200245 000
10705034562667 K200245 000
10705034562650 K200245 000
10705034562643 K200245 000
10705034562605 K200245 000
10705034562582 K200245 000
10705034562575 K200245 000
10705034562544 K200245 000
10705034562520 K200245 000
10705034562506 K200245 000
10705034562483 K200245 000
10705034562476 K200245 000
10705034562711 K200245 000
10705034562452 K200245 000
10705034562681 K200245 000
10705034562674 K200245 000
10705034562636 K200245 000
10705034562629 K200245 000
10705034562612 K200245 000
10705034562599 K200245 000
10705034562568 K200245 000
10705034562551 K200245 000
10705034562537 K200245 000
10705034562513 K200245 000
10705034562490 K200245 000
10705034562469 K200245 000
10705034562445 K200245 000

Trademark Results [EXPEDIUM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EXPEDIUM
EXPEDIUM
78421902 3072007 Live/Registered
DePuy Synthes, Inc.
2004-05-19

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