K253472

Substantially Equivalent

FIREFLY® Pedicle Screw Navigation Guide

Applicant: Mighty Oak Medical
Product code: PQC
Advisory panel: Orthopedic
Date received: 2025-10-10
Decision date: 2026-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

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