Mighty Oak Medical, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 9
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K253472 | FIREFLY® Pedicle Screw Navigation Guide | February 25, 2026 |
| K252103 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | December 2, 2025 |
| K251532 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | November 3, 2025 |
| K234009 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | July 12, 2024 |
| K220132 | FIREFLY® Cervical Navigation Guide | October 26, 2022 |
| K181883 | FIREFLY® Midline Navigation Guide | October 3, 2018 |
| K181399 | FIREFLY® Pedicle Screw Navigation Guide | July 24, 2018 |
| K162419 | FIREFLY® Pedicle Screw Navigation Guide | October 28, 2016 |
| K143222 | FIREFLY Pedicle Screw Navigation Guide | December 11, 2015 |