CMORE® CT System; CMORE® CT System Navigated Instruments— 510(k) K252327

Substantially Equivalent

Icotec AG

FDA 510(k) clearance K252327 for CMORE® CT System; CMORE® CT System Navigated Instruments, Substantially Equivalent on 2025-11-12. Applicant: Icotec AG.

Clearance details

Applicant: Icotec AG
Product code: Code NKG
Advisory panel: Orthopedic
Date received: 2025-07-25
Decision date: 2025-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Altstaetten, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKG

product code NKG

Death: 15
Injury: 1,090
Malfunction: 529
Total: 1,634

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.