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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 the device name listed in this FDA 510(k) record. The listed applicant is Mighty Oak Medical. It received FDA 510(k) clearance on 2026-02-25 under 510(k) 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. The listed applicant is Mighty Oak Medical. The 510(k) number is K253472.

When did FIREFLY® Pedicle Screw Navigation Guide receive FDA 510(k) clearance?

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

Who is the listed applicant for FIREFLY® Pedicle Screw Navigation Guide?

The FDA 510(k) record lists Mighty Oak Medical as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05565131Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine SurgeryCOMPLETED

Other records listing Mighty Oak Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260322Acorn 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)K234009Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)K220132FIREFLY® Cervical Navigation GuideK181883FIREFLY® Midline Navigation Guide

View all 9 devices →

Related Devices (Code: PQC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231483MySpine Unilateral GuidesMedacta International S.A.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.K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SAK181883FIREFLY® 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.

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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