DIANA FUSION CAGE— 510(k) K091122

Substantially Equivalent

Signus Medical

FDA 510(k) clearance K091122 for DIANA FUSION CAGE, Substantially Equivalent on 2009-09-18. Applicant: Signus Medical.

Clearance details

Applicant: Signus Medical
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2009-04-17
Decision date: 2009-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.