Cleared Special

CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head)

K232141 · Medtronic Sofamor Danek USA, Inc. · Orthopedic

Aug 2023

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K232141 is an FDA 510(k) clearance for the CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head), 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 August 16, 2023, 29 days after receiving the submission on July 18, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K232141 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 18, 2023
Decision Date	August 16, 2023
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.