Noblesville, IN, US · 12 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | 3 | 2020-05-21 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | 2 | 2024-03-22 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | 2 | 2023-07-20 |
| OUR | Sacroiliac Joint Fixation | Class II | Orthopedic | 1 | 2025-03-14 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | 1 | 2022-03-31 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | 1 | 2020-12-15 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | 1 | 2020-03-23 |
| PLR | — | — | — | 1 | 2020-02-24 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-03-14 | K243838 | NEXXT MATRIXX® SI System | OUR | Class II | Orthopedic |
| 2024-03-22 | K240690 | STRUXXURE® MCS Anterior Cervical Plate System | KWQ | Class II | Orthopedic |
| 2023-07-20 | K231799 | INERTIA® CONNEXX Modular Pedicle Screw System | NKB | Class II | Orthopedic |
| 2022-07-28 | K221905 | INERTIA CONNEXX Modular Pedicle Screw System | NKB | Class II | Orthopedic |
| 2022-03-31 | K220291 | NEXXT SPINE NAVIGATION System | OLO | Class II | Neurology |
| 2020-12-15 | K202230 | NEXXT MATRIXX Stand Alone ALIF System | OVD | Class II | Orthopedic |
| 2020-09-17 | K202192 | STRUXXURE®-L and STRUXXURE®-A Plate System | KWQ | Class II | Orthopedic |
| 2020-05-21 | K200969 | NEXXT MATRIXX System | MAX | Class II | Orthopedic |
| 2020-03-23 | K200543 | NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System | OVE | Class II | Orthopedic |
| 2020-02-24 | K193412 | NEXXT MATRIXX System | PLR | — | — |
| 2020-01-21 | K193370 | Nexxt Matrixx System | MAX | Class II | Orthopedic |
| 2020-01-09 | K192687 | TrellOss-L MPF | MAX | Class II | Orthopedic |