West Chester, PA, US · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | 3 | 2022-09-16 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | 1 | 2025-05-08 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | 1 | 2022-04-19 |
| NKG | Posterior Cervical Screw System | Class II | Orthopedic | 1 | 2021-08-20 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-05-08 | K243419 | Altus Spine Navigation System | OLO | Class II | Neurology |
| 2022-09-16 | K211027 | Altus Spine Pedicle Screw System | NKB | Class II | Orthopedic |
| 2022-04-19 | K211837 | Altus Spine Interbody Standalone Fusion System | OVD | Class II | Orthopedic |
| 2021-08-20 | K210887 | Altus Spine Sochi OCT Spinal System | NKG | Class II | Orthopedic |
| 2021-01-26 | K200922 | Altus Spine HA Pedicle Screw System | NKB | Class II | Orthopedic |
| 2020-06-02 | K200322 | Altus Spine Pedicle Screw System | NKB | Class II | Orthopedic |