BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    FIREFLY® Pedicle Screw Navigation Guide

    K Number: K253472 · Decision Feb 25, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    7
    Applicant Total
    5
    Review Days
    138

    Basic Information

    Device Name
    FIREFLY® Pedicle Screw Navigation Guide
    K Number
    K253472
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mighty Oak Medical
    Date Received
    October 10, 2025
    Decision Date
    February 25, 2026
    Product Code
    PQC
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PQC Pedicle Screw Placement Guide

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