KAINOS+— 510(k) K090387

Substantially Equivalent

Signus Medizintechnik GmbH

FDA 510(k) clearance K090387 for KAINOS+, Substantially Equivalent on 2009-09-28. Applicant: Signus Medizintechnik GmbH.

Clearance details

Applicant: Signus Medizintechnik GmbH
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2009-02-17
Decision date: 2009-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chesterland, OH, US

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.