BLUE MOUNTAIN CERVICAL PLATE— 510(k) K112809

Substantially Equivalent

Qualgenix, LLC

FDA 510(k) clearance K112809 for BLUE MOUNTAIN CERVICAL PLATE, Substantially Equivalent on 2012-06-20. Applicant: Qualgenix, LLC.

Clearance details

Applicant: Qualgenix, LLC
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2011-09-27
Decision date: 2012-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxford, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.