CYLOX® ST— 510(k) K243188

Substantially Equivalent

Signus Medizintechnik GmbH

FDA 510(k) clearance K243188 for CYLOX® ST, Substantially Equivalent on 2025-02-11. Applicant: Signus Medizintechnik GmbH.

Clearance details

Applicant: Signus Medizintechnik GmbH
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2024-09-30
Decision date: 2025-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alzenau, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

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.