SABER-C System— 510(k) K250540

Substantially Equivalent

Elevation Spine

FDA 510(k) clearance K250540 for SABER-C System, Substantially Equivalent on 2025-08-08. Applicant: Elevation Spine.

Clearance details

Applicant: Elevation Spine
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2025-02-24
Decision date: 2025-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monteray, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

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.