CD Horizon Spinal System— 510(k) K182928

Name: FDA 510(k) clearance K182928
Creator: U.S. Food and Drug Administration
Published: 2019-01-11

Substantially Equivalent

Medtronic Sofamor Danek USA, Inc.

FDA 510(k) clearance K182928 for CD Horizon Spinal System, Substantially Equivalent on 2019-01-11. Applicant: Medtronic Sofamor Danek USA, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic Sofamor Danek USA, Inc.
Product code: Code NQP
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2018-10-22
Decision date: 2019-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NQP

view all

K203678 — CD HORIZON Spinal System2021-01-15
K191066 — CD Horizon Astute Spinal System2019-10-03
K133164 — DYNESYS TOP-LOADING SPINAL SYSTEM2014-01-16
K101704 — ZIMMER DTO PIN PRESS INSTRUMENT2010-08-18
K101083 — DSS STABILIZATION SYSTEM2010-07-02

More clearances from Medtronic Sofamor Danek USA, Inc.

view all

K253011 — Catalyft PL Expandable Interbody System2026-07-17
K261020 — Symmetrix L Spinal System2026-07-14
K253656 — OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System2026-06-05
K260216 — CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System2026-04-21
K254165 — Infinity OCT System2026-01-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.