# Mighty Oak Medical, Inc.

- Location (FDA's records): Englewood, CO
- FDA decisions: 10 (2015–2026): 10 510(k) clearances
- Names in FDA's records: Mighty Oak Medical, Inc. (5); Mighty Oak Medical (5)
- Product codes: PQC (4), QIH (3), MNI (1), LLZ (1), QSD (1)
- 510(k) review time since 2016: median 142 days, against 136 for FDA's reviews in the same codes and years (2 of 6 faster)
- Predicates its devices cite: 13 (7 its own); citations of its devices by later devices: 10 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medacta International S.A.: 1 (https://510kreport.com/company/medacta-international)
- Materialise NV: 1 (https://510kreport.com/company/materialise)
- 3D Systems, Inc.: 1 (https://510kreport.com/company/3d-systems)
- Eos Imaging: 1 (https://510kreport.com/company/eos-imaging)
- Nemaris, Inc.: 1 (https://510kreport.com/company/nemaris)
- Zimmer Spine, Inc.: 1 (https://510kreport.com/company/zimmer-spine)

## Firms that cite its devices most
- Medacta International S.A.: 3 (https://510kreport.com/company/medacta-international)

## Its most-cited devices
- K162419: FIREFLY® Pedicle Screw Navigation Guide (2016), cited by 2
- K234009: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (2024), cited by 2
- K181399: FIREFLY® Pedicle Screw Navigation Guide (2018), cited by 2
- K143222: FIREFLY Pedicle Screw Navigation Guide (2015), cited by 1
- K181883: FIREFLY® Midline Navigation Guide (2018), cited by 1
- K252103: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (2025), cited by 1

## Recent decisions
- K260322: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (Jun 11, 2026)
- K253472: FIREFLY® Pedicle Screw Navigation Guide (Feb 25, 2026)
- K252103: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (Dec 2, 2025)
- K251532: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (Nov 3, 2025)
- K234009: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (Jul 12, 2024)
- K220132: FIREFLY® Cervical Navigation Guide (Oct 26, 2022)
- K181883: FIREFLY® Midline Navigation Guide (Oct 3, 2018)
- K181399: FIREFLY® Pedicle Screw Navigation Guide (Jul 24, 2018)

Source page: https://510kreport.com/company/mighty-oak-medical