Orthofix US, LLC
Medical device manufacturer in Lewisville, TX.
4510(k) clearances
1PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K252088 | Firebird SI Navigation SystemOLO · Traditional | 10/31/2025SE |
| K230252 | OFIX MIS AppLLZ · Traditional | 09/26/2023SE |
| K211712 | 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…KWQ · Traditional | 02/11/2022SE |
| K213951 | FORZA XP Expandable Spacer SystemMAX · Special | 01/05/2022SE |
PMA approvals
- P210035 AccelStimTM Bone Growth Stimulator · 05/03/2022 · 2 supplements