Cleared Traditional

VADER? Pedicle System, G21 Cement

K222789 · Icotec AG · Orthopedic

Jan 2023

Decision

116d

Days

Class 2

Risk

About This 510(k) Submission

K222789 is an FDA 510(k) clearance for the VADER? Pedicle System, G21 Cement, a Bone Cement, Posterior Screw Augmentation (Class II — Special Controls, product code PML), submitted by Icotec AG (9450 Altstaetten (Sg), CH). The FDA issued a Cleared decision on January 9, 2023, 116 days after receiving the submission on September 15, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number	K222789 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 15, 2022
Decision Date	January 09, 2023
Days to Decision	116 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PML — Bone Cement, Posterior Screw Augmentation
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3027
Definition	The Device Is Intended To Augment The Fixation Of Screws In A Posterior Spinal System Construct.