Cleared Special

CD Horizon Spinal System

K211596 · Medtronic · Orthopedic
Jun 2021
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K211596 is an FDA 510(k) clearance for the CD Horizon Spinal System, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Medtronic (Memphis, US). The FDA issued a Cleared decision on June 23, 2021, 30 days after receiving the submission on May 24, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K211596 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2021
Decision Date June 23, 2021
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code OLO — Orthopedic Stereotaxic Instrument
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.

Similar Devices — OLO Orthopedic Stereotaxic Instrument

All 414
TMINI? Miniature Robotic System
K260010 · THINK Surgical, Inc. · Mar 2026
Mako Total Knee Application
K260222 · Mako Surgical Corp. · Feb 2026
?POINT? Kinguide Agile Hybrid Navigation System; DRF Accessories Set
K252989 · Point Robotics MedTech, Inc. · Feb 2026
Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)
K252597 · Alphatec Spine, Inc. · Feb 2026
Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor
K253623 · Stryker Leibinger GmbH & Co KG · Feb 2026
VERTICALE GPS Instruments
K254148 · Silony Medical GmbH · Feb 2026

More from Medtronic

View all
Affinity Pixie? Arterial Filter with Balance? Biosurface; Affinity? Pediatric Arterial Blood Filter
K251744 · DTM · Jan 2026
Sphere-9Dx Diagnostic Catheter (AFR-00009)
K233433 · MTD · Aug 2024
MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated
K240190 · DTR · Feb 2024
CD Horizon Spinal System
K223494 · NKB · Jan 2023
SelectSite C304 Deflectable Catheter System, C315 Delivery System
K223178 · DQY · Nov 2022