Cleared Traditional

CD Horizon? Spinal System

K210637 · Medtronic · Orthopedic

Apr 2021

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K210637 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 April 30, 2021, 58 days after receiving the submission on March 3, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K210637 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 03, 2021
Decision Date	April 30, 2021
Days to Decision	58 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.