CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System— 510(k) K260216

Name: FDA 510(k) clearance K260216
Creator: U.S. Food and Drug Administration
Published: 2026-04-21

Substantially Equivalent

Medtronic Sofamor Danek USA, Inc.

FDA 510(k) clearance K260216 for CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System, Substantially Equivalent on 2026-04-21. Applicant: Medtronic Sofamor Danek USA, Inc.. Device class: 2.

Summary

Medtronic Sofamor Danek USA's record names two items: the CD Horizon ModuLeX Fenestrated Screw Set and the CD Horizon ModuLeX Spinal System. Both are filed under product code NKB (Thoracolumbosacral Pedicle Screw System).

Class II, 21 CFR 888.3070. It came in as a Traditional 510(k), and Orthopedic is both the classification panel and the review panel.

Medtronic Sofamor Danek USA filed from Memphis, Tennessee. Review took 88 calendar days (January 23 to April 21, 2026).

Clearance details

Applicant: Medtronic Sofamor Danek USA, Inc.
Product code: Product code NKB
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2026-01-23
Decision date: 2026-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NKB

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K262731 — Virata Spinal Fixation System2026-10-29
K261217 — AnyPlus II Spinal Fixation System2026-10-02
K263062 — NOVIX Pedicle Screw System2026-10-01
K262712 — Duet Spinal Fixation System2026-09-30
K263172 — SAS MIS Pelvic Incidence Rods2026-09-30

More clearances from Medtronic Sofamor Danek USA, Inc.

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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
K254165 — Infinity OCT System2026-01-21

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.