FORTICO Anterior Cervical Fixation System— 510(k) K191584

Substantially Equivalent

Camber Spine Technologies, LLC

FDA 510(k) clearance K191584 for FORTICO Anterior Cervical Fixation System, Substantially Equivalent on 2019-10-22. Applicant: Camber Spine Technologies, LLC.

Clearance details

Applicant: Camber Spine Technologies, LLC
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2019-06-14
Decision date: 2019-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: King Of Prussia, PA, 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.