Columbia City, IN, US · 3 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | 1 | 2024-09-05 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | 1 | 2023-06-02 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | 1 | 2020-12-22 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-09-05 | K241605 | Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology | MAX | Class II | Orthopedic |
| 2023-06-02 | K230936 | Anatomic PEEK Cervical Fusion System with Nanotechnology | ODP | Class II | Orthopedic |
| 2020-12-22 | K203452 | Nano FortiFix® System | NKB | Class II | Orthopedic |