XTANT Medical Holdings, Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 1
- Inspections
- 14
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1177-2025 | Class II | Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11 | January 3, 2025 |
| Z-0125-2025 | Class II | Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045 | August 21, 2024 |
| Z-0846-2024 | Class II | Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter | November 28, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K241892 | Cortera Spinal Fixation System | August 2, 2024 |