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

    FIREFLY® Midline Navigation Guide

    K Number: K181883 · Decision Oct 3, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    7
    Applicant Total
    5
    Review Days
    82

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    Basic Information

    Device Name
    FIREFLY® Midline Navigation Guide
    K Number
    K181883
    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, Inc.
    Date Received
    July 13, 2018
    Decision Date
    October 3, 2018
    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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    Other Clearances by Mighty Oak Medical, Inc.

    K Number Device Name
    K220132 FIREFLY® Cervical Navigation Guide
    K181399 FIREFLY® Pedicle Screw Navigation Guide
    K162419 FIREFLY® Pedicle Screw Navigation Guide
    K143222 FIREFLY Pedicle Screw Navigation Guide