ACCIN BIPOLAR HEAD SYSTEM— 510(k) K080647

Substantially Equivalent

Accelerated Innovation, LLC

FDA 510(k) clearance K080647 for ACCIN BIPOLAR HEAD SYSTEM, Substantially Equivalent on 2008-07-08. Applicant: Accelerated Innovation, LLC.

Clearance details

Applicant: Accelerated Innovation, LLC
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 2008-03-07
Decision date: 2008-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clifton, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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.