9450 Altstaetten (Sg), CH · 13 510(k) clearances · 3 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | 3 | 2025-02-27 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | 2 | 2024-05-17 |
| MQP | Spinal Vertebral Body Replacement Device | Class II | Orthopedic | 2 | 2024-04-04 |
| PML | Bone Cement, Posterior Screw Augmentation | Class II | Orthopedic | 2 | 2023-01-09 |
| NKG | Posterior Cervical Screw System | Class II | Orthopedic | 1 | 2025-11-12 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | 1 | 2024-04-05 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | 1 | 2023-06-27 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | 1 | 2020-03-20 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-11-28 | Class II | Ongoing | Z-0701-2024 | VADER pedicle system, torque wrench, Catalog Number 42-703 | — | icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved… |
| 2023-11-28 | Class II | Ongoing | Z-0700-2024 | VADER pedicle system, torque wrench, Catalog Number 42-702 | — | icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved… |
| 2022-11-03 | Class II | Ongoing | Z-0728-2023 | VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702 | — | During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The spe… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-11-12 | K252327 | CMORE® CT System; CMORE® CT System Navigated Instruments | NKG | Class II | Orthopedic |
| 2025-02-27 | K242900 | VADER® Pedicle System and VADER®one Pedicle System | NKB | Class II | Orthopedic |
| 2024-05-17 | K233215 | icotec Anterior Cervical Plate System | KWQ | Class II | Orthopedic |
| 2024-04-05 | K232792 | icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage) | MAX | Class II | Orthopedic |
| 2024-04-04 | K232790 | KONG®-TL VBR System and KONG® C VBR System | MQP | Class II | Orthopedic |
| 2024-02-26 | K232628 | VADER® Pedicle System | NKB | Class II | Orthopedic |
| 2023-06-27 | K230861 | VADER® Pedicle System Navigated Instruments | OLO | Class II | Neurology |
| 2023-01-09 | K222789 | VADER® Pedicle System, G21 Cement | PML | Class II | Orthopedic |
| 2020-10-15 | K201587 | icotec Anterior Cervical Plate System | KWQ | Class II | Orthopedic |
| 2020-10-13 | K200596 | G21 Cement, VADER® Pedicle System | PML | Class II | Orthopedic |
| 2020-05-29 | K200235 | KONG-TL VBR System, KONG-C VBR System | MQP | Class II | Orthopedic |
| 2020-05-22 | K193423 | VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 | NKB | Class II | Orthopedic |
| 2020-03-20 | K192897 | icotec Cervical Cage | ODP | Class II | Orthopedic |