Lewisville, TX, US · 4 510(k) clearances · 3 PMAs
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | 1 | 2025-10-31 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 1 | 2023-09-26 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | 1 | 2022-02-11 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | 1 | 2022-01-05 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2025-03-21 | P210035-S003 | AccelStim | Normal 180 Day Track | LOF | Stimulator, Bone Growth, Non-Invasive | Orthopedic |
| 2024-07-11 | P210035-S002 | AccelStim | Real-Time Process | LOF | Stimulator, Bone Growth, Non-Invasive | Orthopedic |
| 2022-05-03 | P210035 | AccelStimTM Bone Growth Stimulator | Original | LOF | Stimulator, Bone Growth, Non-Invasive | Orthopedic |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-10-31 | K252088 | Firebird SI Navigation System | OLO | Class II | Neurology |
| 2023-09-26 | K230252 | OFIX MIS App | LLZ | Class II | Radiology |
| 2022-02-11 | K211712 | 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System | KWQ | Class II | Orthopedic |
| 2022-01-05 | K213951 | FORZA XP Expandable Spacer System | MAX | Class II | Orthopedic |