Surgalign Spine Technologies
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 3
- Inspections
- 3
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K231611 | HOLO Portal Surgical Guidance System | August 31, 2023 |
| K221403 | Cortera Spinal Fixation System | August 19, 2022 |
| K211254 | ARAI Surgical Navigation System | January 14, 2022 |