Icotec AG
Medical device manufacturer in Altstaetten, CH.
17510(k) clearances
0PMA approvals
3recalls
Device types
- NKB Thoracolumbosacral Pedicle Screw System 5
- MAX Intervertebral Fusion Device With Bone… 2
- ODP Intervertebral Fusion Device With Bone… 2
- MQP Spinal Vertebral Body Replacement Device 2
- PML Bone Cement, Posterior Screw Augmentation 2
- KWQ Appliance, Fixation, Spinal Intervertebral… 2
- OLO Orthopedic Stereotaxic Instrument 1
- NKG Posterior Cervical Screw System 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K252327 | CMORE® CT System; CMORE® CT System Navigated InstrumentsNKG · Traditional | 11/12/2025SE |
| K242900 | VADER® Pedicle System and VADER®one Pedicle SystemNKB · Traditional | 02/27/2025SE |
| K233215 | icotec Anterior Cervical Plate SystemKWQ · Traditional | 05/17/2024SE |
| K232792 | icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…MAX · Traditional | 04/05/2024SE |
| K232790 | KONG®-TL VBR System and KONG® C VBR SystemMQP · Traditional | 04/04/2024SE |
| K232628 | VADER® Pedicle SystemNKB · Traditional | 02/26/2024SE |
| K230861 | VADER® Pedicle System Navigated InstrumentsOLO · Traditional | 06/27/2023SE |
| K222789 | VADER® Pedicle System, G21 CementPML · Traditional | 01/09/2023SE |
| K201587 | icotec Anterior Cervical Plate SystemKWQ · Traditional | 10/15/2020SE |
| K200596 | G21 Cement, VADER® Pedicle SystemPML · Traditional | 10/13/2020SE |
| K200235 | KONG-TL VBR System, KONG-C VBR SystemMQP · Traditional | 05/29/2020SE |
| K193423 | VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0NKB · Traditional | 05/22/2020SE |
| K192897 | icotec Cervical CageODP · Traditional | 03/20/2020SE |
| K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0NKB · Traditional | 06/20/2019SE |
| K172480 | icotec Interbody Cage SystemODP · Traditional | 05/17/2018SE |
| K151977 | icotec Pedicle SystemNKB · Traditional | 04/12/2016SE |
| K100305 | Eturn Spinal Implant Model Eturn XX-12; Eturn XX-16 Where XX=07, 09, 11, 13, or 15 and…MAX · Traditional | 07/21/2011SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0701-2024 Class II | VADER pedicle system, torque wrench, Catalog Number 42-703icotec has received notification of one revision that had to be carried out because nut screws had become… | 11/28/2023Open, Classified |
| Z-0700-2024 Class II | VADER pedicle system, torque wrench, Catalog Number 42-702icotec has received notification of one revision that had to be carried out because nut screws had become… | 11/28/2023Open, Classified |
| Z-0728-2023 Class II | VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque… | 11/03/2022Open, Classified |