Cleared Traditional

VADER? Pedicle System

K232628 · Icotec AG · Orthopedic

Feb 2024

Decision

181d

Days

Class 2

Risk

About This 510(k) Submission

K232628 is an FDA 510(k) clearance for the VADER? Pedicle System, 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 February 26, 2024, 181 days after receiving the submission on August 29, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K232628 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 29, 2023
Decision Date	February 26, 2024
Days to Decision	181 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.