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FDA 510(k)

FIREFLY® Pedicle Screw Navigation Guide

K-Number: K253472 · 2026-02-25

ApplicantMighty Oak Medical
Decision Date2026-02-25
Product CodePQC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FIREFLY® Pedicle Screw Navigation Guide is a medical device manufactured by Mighty Oak Medical. It received FDA 510(k) clearance on 2026-02-25 under approval number K253472. The device is classified under product code PQC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIREFLY® Pedicle Screw Navigation Guide?

FIREFLY® Pedicle Screw Navigation Guide is a medical device that received FDA 510(k) clearance on 2026-02-25. It is manufactured by Mighty Oak Medical. The 510(k) number is K253472.

When was FIREFLY® Pedicle Screw Navigation Guide approved by the FDA?

FIREFLY® Pedicle Screw Navigation Guide received FDA 510(k) clearance on 2026-02-25, under approval number K253472.

What company makes FIREFLY® Pedicle Screw Navigation Guide?

FIREFLY® Pedicle Screw Navigation Guide is manufactured by Mighty Oak Medical.

What is the FDA product code for FIREFLY® Pedicle Screw Navigation Guide?

The FDA product code for FIREFLY® Pedicle Screw Navigation Guide is PQC.

Related Clinical Trials

NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT07271238 Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures RECRUITING NCT07210151 Anatomical Navigation for Guided Electrophysiology in AFL and AFib RECRUITING

Related PubMed Literature

PMID: 41487949 Verification, validation, and uncertainty quantification of finite element analysis results for pedicle screw assemblies under ASTM F1717 flexion and extension testing. Frontiers in bioengineering and biotechnology (2025)

Other Devices by Mighty Oak Medical

K234009Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) K251532Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

Related Devices (Code: PQC)

K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc. K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc. K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc. K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A. K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)Medacta International S.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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