Medical Device Manufacturer · SE , Altstaetten

Icotec AG - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2016

Recent clearances: CMORE® CT System, VADER® Pedicle System and VADER®one Pedicle System, icotec Anterior Cervical Plate System

16
Total
16
Cleared
0
Denied

Icotec AG has 16 FDA 510(k) cleared orthopedic devices. Based in Altstaetten, SE.

Latest FDA clearance: Nov 2025. Active since 2016.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Mcra, LLC, Musculoskeletal Clinical Regulatory Affairs and Musculosketal Clinical Regulatory Affairs. 2 devices have linked clinical trials registered on ClinicalTrials.gov.

FDA 510(k) Regulatory Record - Icotec AG

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