INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE— 510(k) K093808

Substantially Equivalent

Incite Innovation, LLC

FDA 510(k) clearance K093808 for INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE, Substantially Equivalent on 2010-03-24. Applicant: Incite Innovation, LLC.

Clearance details

Applicant: Incite Innovation, LLC
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2009-12-11
Decision date: 2010-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Springfield, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.