Cleared Special

CD Horizon? Spinal System

K243007 · Medtronic Sofamor Danek USA, Inc. · Orthopedic

Oct 2024

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K243007 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 Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on October 23, 2024, 27 days after receiving the submission on September 26, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K243007 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2024
Decision Date	October 23, 2024
Days to Decision	27 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.