Cleared Traditional

CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)

K233951 · Medtronic Sofamor Danek USA, Inc. · Orthopedic

Mar 2024

Decision

103d

Days

Class 2

Risk

About This 510(k) Submission

K233951 is an FDA 510(k) clearance for the CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw), 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 March 27, 2024, 103 days after receiving the submission on December 15, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K233951 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 2023
Decision Date	March 27, 2024
Days to Decision	103 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.