CD HORIZON SPINAL SYSTEM— 510(k) K041460

Name: FDA 510(k) clearance K041460
Creator: U.S. Food and Drug Administration
Published: 2004-07-01

Substantially Equivalent

Medtronic Sofamor Danek USA, Inc.

FDA 510(k) clearance K041460 for CD HORIZON SPINAL SYSTEM, Substantially Equivalent on 2004-07-01. Applicant: Medtronic Sofamor Danek USA, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic Sofamor Danek USA, Inc.
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2004-06-02
Decision date: 2004-07-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWQ

view all

K261309 — Palisades Buttress Plate System2026-07-16
K252776 — ARIES Anterior Cervical Plate Systems2026-05-14
K261112 — CastleLoc-P Anterior Cervical Plate System2026-05-06
K260570 — corra cervical plating system2026-04-22
K260697 — VyPlate Anterior Cervical Plate System2026-03-27

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

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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