INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE— 510(k) K122008

Substantially Equivalent

Incite Innovation, LLC

FDA 510(k) clearance K122008 for INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE, Substantially Equivalent on 2012-11-16. Applicant: Incite Innovation, LLC.

Clearance details

Applicant: Incite Innovation, LLC
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2012-07-09
Decision date: 2012-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Springfield, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

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.