MODIFICATION TO CERASORB ORTHO— 510(k) K031651

Substantially Equivalent

Curasan AG

FDA 510(k) clearance K031651 for MODIFICATION TO CERASORB ORTHO, Substantially Equivalent on 2003-08-13. Applicant: Curasan AG.

Clearance details

Applicant: Curasan AG
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2003-05-28
Decision date: 2003-08-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Kleinostheim, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQV

product code MQV

Death: 6
Injury: 435
Total: 441

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.