Ventana A Anterior Lumbar Interbody System— 510(k) K253559

Substantially Equivalent

Spinal Elements, Inc.

FDA 510(k) clearance K253559 for Ventana A Anterior Lumbar Interbody System, Substantially Equivalent on 2026-02-25. Applicant: Spinal Elements, Inc..

Clearance details

Applicant: Spinal Elements, Inc.
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2025-11-17
Decision date: 2026-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.