Cleared Traditional

VADER?one Pedicle System MIS and LightMore? Pedicle System 6.0

K193423 · Icotec AG · Orthopedic

May 2020

Decision

165d

Days

Class 2

Risk

About This 510(k) Submission

K193423 is an FDA 510(k) clearance for the VADER?one Pedicle System MIS and LightMore? Pedicle System 6.0, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Icotec AG (9450 Altstaetten (Sg), CH). The FDA issued a Cleared decision on May 22, 2020, 165 days after receiving the submission on December 9, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K193423 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 09, 2019
Decision Date	May 22, 2020
Days to Decision	165 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKB — Thoracolumbosacral Pedicle Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.