XTANT Medical Holdings, Inc
FDA Regulatory Profile
XTANT Medical Holdings, Inc appears in FDA public data with 5 recalls, 1 510(k) clearance, 14 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-1897-2026, Class II) was initiated on March 9, 2026. Its most recent 510(k) clearance was granted on August 2, 2024.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 1
- Inspections
- 14
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1897-2026 | Class II | nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-25 | March 9, 2026 |
| Z-1773-2026 | Class II | XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL. | February 18, 2026 |
| 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 |