VADER® One Pedicle System MIS And LightMore® Pedicle System 6.0

Thoracolumbosacral Pedicle Screw System

Icotec Ag

The following data is part of a premarket notification filed by Icotec Ag with the FDA for Vader® One Pedicle System Mis And Lightmore® Pedicle System 6.0.

Pre-market Notification Details

• Device ID: K190545
• 510k Number: K190545
• Device Name: VADER® One Pedicle System MIS And LightMore® Pedicle System 6.0
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: icotec Ag Industriestrasse 12 9450 Altstaetten, CH
• Contact: Marina Hess
• Correspondent: Justin Eggleton; Musculosketal Clinical Regulatory Affairs 1050 K Street NW, Suite 1000 Washington, DC 20001
• Product Code: NKB
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-03-04
• Decision Date: 2019-06-20