MagnetOs Flex Matrix— 510(k) K213959

Substantially Equivalent

Kuros Biosciences B.V

FDA 510(k) clearance K213959 for MagnetOs Flex Matrix, Substantially Equivalent on 2022-04-14. Applicant: Kuros Biosciences B.V.

Clearance details

Applicant: Kuros Biosciences B.V
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2021-12-17
Decision date: 2022-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bilthoven, NL

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.