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 ID: K200245
• 510k Number: K200245
• Device Name: EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: Medos International Sàrl Chemin-Blanc 38 Le Locle, CH 2400
• Contact: Rhoda Maddonni
• Correspondent: Rhoda Maddonni; DePuy Synthes Spine 325 Paramount Drive Raynham, MA 02767
• Product Code: NKB
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-01-31
• Decision Date: 2020-04-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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