CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly)— 510(k) K253941

Substantially Equivalent

Medtronic Sofamor Danek USA, Inc.

FDA 510(k) clearance K253941 for CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly), Substantially Equivalent on 2026-01-07. Applicant: Medtronic Sofamor Danek USA, Inc..

Clearance details

Applicant: Medtronic Sofamor Danek USA, Inc.
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2025-12-09
Decision date: 2026-01-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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.