FIREFLY® Pedicle Screw Navigation Guide— 510(k) K253472

Substantially Equivalent

Mighty Oak Medical

FDA 510(k) clearance K253472 for FIREFLY® Pedicle Screw Navigation Guide, Substantially Equivalent on 2026-02-25. Applicant: Mighty Oak Medical.

Clearance details

Applicant
Mighty Oak Medical
Product code
Code PQC
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Englewood, CO, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.