icotec ag
CH-MF-000026833 · Switzerland · Altstätten
icotec ag is registered in the European database on medical devices as a manufacturer, with 481 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 366 |
|---|---|
| Class IIb | 115 |
Most frequent device types declared: Container Nav., Distractor, Drill, Drill Sleeve, Lordotic Probe.
Among these devices, 115 are declared sterile, 115 implantable, 58 reusable.
Authorised representative in the Union: icotec Medical GmbH.
Devices declared under this manufacturer
- KONG®-C VBR System Trial End Plate <3° 14 x 13 mm
- VADER® Pedicle System Pedicle Probe, curved for 6.5 mm Screw
- VADER® Pedicle System Rod Pusher
- VADER® Pedicle System Rod, Carbon/PEEK, Curved Ø 6.0 r120 ↔ 080 mm
- VADER® Pedicle System T-Handle, Ratchet ¼\
- VADER® Pedicle System, Trial rod, flexible, Ø 5.5 mm; L = 300 mm
- VADER® Pedicle System, VADER® Pedicle System Navigated Instruments, Co
- icotec Anterior Cervical Plate System Drill Sleeve for Template SW 4 m
- icotec Anterior Cervical Plate System Drill, AO coupling Ø 3mm for 13
- icotec Anterior Cervical Plate System Grip, AO Coupling
- icotec Cervical Cage, Anatomic Probe, ↕ 8 mm ↔ 16 mm
- icotec Cervical Cage, Lordotic Probe, ↕ 6 mm ↔ 16 mm
Showing 12 of 481 declared devices.
Catalogue references include 16-60-71208, 38-007-011, 39-20, 39-3-13, 41-4-0616, 42-540.
European nomenclature codes declared: L1109, P09070302, P09070101, L1111, L1112, L1110.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ICOTEC AG (CH) · FDA 3006493760 |
| Devices in EUDAMED | 481 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 481 |
|---|---|
| Found in the U.S. device database | 475 |
| Share | 98.8 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ICOTEC AG |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 2 |
| First licensed | 2026-01-28 |
Licence types: System (2).
Licensed under: KONG VBRS, VADER PEDICLE SYSTEM.
North American profile: Both markets. icotec ag is registered in both the United States and Canada.