Cleared Special

CD Horizon? Spinal System

K221244 · Medtronic · Orthopedic

May 2022

Decision

23d

Days

Class 2

Risk

About This 510(k) Submission

K221244 is an FDA 510(k) clearance for the CD Horizon? Spinal System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Medtronic (Memphis, US). The FDA issued a Cleared decision on May 25, 2022, 23 days after receiving the submission on May 2, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K221244 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 2022
Decision Date	May 25, 2022
Days to Decision	23 days
Submission Type	Special
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.