Ventana A Anterior Lumbar Interbody System— 510(k) K253559
Substantially EquivalentSpinal Elements, Inc.
FDA 510(k) clearance K253559 for Ventana A Anterior Lumbar Interbody System, Substantially Equivalent on 2026-02-25. Applicant: Spinal Elements, Inc.. Device class: 2.
Summary
Spinal Elements' Ventana A Anterior Lumbar Interbody System is filed under product code OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar). The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).
Spinal Elements filed from Carlsbad, California. FDA found it substantially equivalent 100 calendar days after receipt (November 17, 2025 to February 25, 2026).
Clearance details
- Applicant
- Spinal Elements, Inc.
- Product code
- Product code OVD
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code OVD
view allMore clearances from Spinal Elements, Inc.
view allAdverse events under product code OVD
product code OVD- Death
- 5
- Injury
- 495
- Total
- 500
Source: openFDA MAUDE database, through . 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.