FDA 510(k)

FIREFLY® Pedicle Screw Navigation Guide

N.º K: K253472 · 2026-02-25

Fecha de decisión2026-02-25

Código de productoPQC

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

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Otros registros que enlistan a Mighty Oak Medical como solicitante

K260322Software Acorn 3D (AC-SEG-4009); Modelo 3DP Acorn (AC-101-XX)K252103Software Acorn 3D (AC-SEG-4009); Modelo 3DP Acorn (AC-101-XX)K251532Software Acorn 3D (AC-SEG-4009); Modelo 3DP Acorn (AC-101-XX)K234009Software Acorn 3D (AC-SEG-4009); Modelo 3DP Acorn (AC-101-XX)

Dispositivos relacionados (Código: PQC)

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 SA 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.

Fuente oficial

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