Genostis Osteosynthesis System— 510(k) K242988

Substantially Equivalent

Genostis AF

FDA 510(k) clearance K242988 for Genostis Osteosynthesis System, Substantially Equivalent on 2025-06-27. Applicant: Genostis AF.

Clearance details

Applicant: Genostis AF
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2024-09-26
Decision date: 2025-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burgdorf, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.