FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE— 510(k) K043500

Substantially Equivalent

Innospine, Inc.

FDA 510(k) clearance K043500 for FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE, Substantially Equivalent on 2005-04-15. Applicant: Innospine, Inc..

Clearance details

Applicant: Innospine, Inc.
Product code: Code BSP
Advisory panel: Anesthesiology
Date received: 2004-12-20
Decision date: 2005-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Altos Hills, CA, US

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Adverse events under product code BSP

product code BSP

Death: 2
Total: 2

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.