K253472
- 510(k) number
- K253472
- Device name
- FIREFLY® Pedicle Screw Navigation Guide
- Applicant
- Mighty Oak Medical CO · US
- Product code
- PQC — Pedicle Screw Placement Guide
- Decision date
- 2026-02-25
- Date received
- 2025-10-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K253472.pdf
Official FDA record: K253472
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.