SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT— 510(k) K081404

Substantially Equivalent

Spinal Integration, LLC

FDA 510(k) clearance K081404 for SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT, Substantially Equivalent on 2008-10-21. Applicant: Spinal Integration, LLC.

Clearance details

Applicant: Spinal Integration, LLC
Product code: Code BSO
Advisory panel: Anesthesiology
Date received: 2008-05-19
Decision date: 2008-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

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Adverse events under product code BSO

product code BSO

Malfunction: 688
Total: 688

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.