Evolution Spine Navigation Instruments— 510(k) K250167

Substantially Equivalent

Evolution Spine

FDA 510(k) clearance K250167 for Evolution Spine Navigation Instruments, Substantially Equivalent on 2025-08-18. Applicant: Evolution Spine.

Clearance details

Applicant: Evolution Spine
Product code: Code OLO
Advisory panel: Neurology
Date received: 2025-01-21
Decision date: 2025-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OLO

product code OLO

Death: 11
Injury: 2,799
Malfunction: 11,105
Other: 1
Total: 13,916

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.