OneLIF Interbody Fusion System— 510(k) K251459

Substantially Equivalent

Novapproach Spine, LLC

FDA 510(k) clearance K251459 for OneLIF Interbody Fusion System, Substantially Equivalent on 2025-06-12. Applicant: Novapproach Spine, LLC.

Clearance details

Applicant: Novapproach Spine, LLC
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2025-05-12
Decision date: 2025-06-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Alachua, FL, 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.