BonOs HV Genta, BonOs MV Genta, BonOs LV Genta— 510(k) K210125

Substantially Equivalent

Osartis GmbH

FDA 510(k) clearance K210125 for BonOs HV Genta, BonOs MV Genta, BonOs LV Genta, Substantially Equivalent on 2021-03-19. Applicant: Osartis GmbH.

Clearance details

Applicant: Osartis GmbH
Product code: Code LOD
Advisory panel: Orthopedic
Date received: 2021-01-19
Decision date: 2021-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Münster, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code LOD

product code LOD

Death: 44
Injury: 3,004
Malfunction: 895
Other: 4
Total: 3,947

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.