Eminent Spine SI Screw System— 510(k) K240505

Substantially Equivalent

Eminent Spine, LLC

FDA 510(k) clearance K240505 for Eminent Spine SI Screw System, Substantially Equivalent on 2024-06-04. Applicant: Eminent Spine, LLC.

Clearance details

Applicant: Eminent Spine, LLC
Product code: Code OUR
Advisory panel: Orthopedic
Date received: 2024-02-21
Decision date: 2024-06-04
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.