G21 Cement, VADER® Pedicle System— 510(k) K200596

Substantially Equivalent

Icotec AG

FDA 510(k) clearance K200596 for G21 Cement, VADER® Pedicle System, Substantially Equivalent on 2020-10-13. Applicant: Icotec AG.

Clearance details

Applicant: Icotec AG
Product code: Code PML
Advisory panel: Orthopedic
Date received: 2020-03-06
Decision date: 2020-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 9450 Altstaetten (Sg), CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code PML

product code PML

Death: 8
Total: 8

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.