Total clearances
6
2022-10-26 → 2026-06-11
Name variants in FDA filings: Mighty Oak Medical, Inc. / Mighty Oak Medical
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| QIH |
Automated Radiological Image Processing Software |
Class II |
Radiology |
3 |
2026-06-11 |
| PQC |
— |
— |
— |
1 |
2026-02-25 |
| LLZ |
System, Image Processing, Radiological |
Class II |
Radiology |
1 |
2025-11-03 |
| QSD |
Posterior Cervical Screw Placement Guide |
Class II |
Orthopedic |
1 |
2022-10-26 |
Filings
All 510(k) clearances (6)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-06-11 |
K260322 |
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) |
QIH |
Class II |
Radiology |
| 2026-02-25 |
K253472 |
FIREFLY® Pedicle Screw Navigation Guide |
PQC |
— |
— |
| 2025-12-02 |
K252103 |
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) |
QIH |
Class II |
Radiology |
| 2025-11-03 |
K251532 |
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) |
LLZ |
Class II |
Radiology |
| 2024-07-12 |
K234009 |
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) |
QIH |
Class II |
Radiology |
| 2022-10-26 |
K220132 |
FIREFLY® Cervical Navigation Guide |
QSD |
Class II |
Orthopedic |