Cleared Special

CD Horizon? ModuLeX? Spinal System (LigaMAS Head Assembly)

K253941 · Medtronic Sofamor Danek USA, Inc. · Orthopedic

Jan 2026

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K253941 is an FDA 510(k) clearance for the CD Horizon? ModuLeX? Spinal System (LigaMAS Head Assembly), 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 January 7, 2026, 29 days after receiving the submission on December 9, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K253941 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 09, 2025
Decision Date	January 07, 2026
Days to Decision	29 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.