Eminent Spine Posterior SI System— 510(k) K250894

Substantially Equivalent

Eminent Spine

FDA 510(k) clearance K250894 for Eminent Spine Posterior SI System, Substantially Equivalent on 2025-10-07. Applicant: Eminent Spine.

Clearance details

Applicant: Eminent Spine
Product code: Code OUR
Advisory panel: Orthopedic
Date received: 2025-03-25
Decision date: 2025-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OUR

product code OUR

Death: 3
Injury: 347
Total: 350

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.