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

    FIREFLY® Cervical Navigation Guide

    K Number: K220132 · Decision Oct 26, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    5
    Review Days
    281

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    Basic Information

    Device Name
    FIREFLY® Cervical Navigation Guide
    K Number
    K220132
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3075
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mighty Oak Medical, Inc.
    Date Received
    January 18, 2022
    Decision Date
    October 26, 2022
    Product Code
    QSD
    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
    QSD Posterior Cervical Screw Placement Guide

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    Other Clearances by Mighty Oak Medical, Inc.

    K Number Device Name
    K181883 FIREFLY® Midline Navigation Guide
    K181399 FIREFLY® Pedicle Screw Navigation Guide
    K162419 FIREFLY® Pedicle Screw Navigation Guide
    K143222 FIREFLY Pedicle Screw Navigation Guide