BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FIREFLY Pedicle Screw Navigation Guide

    Reg #: 3011818499 · FEI: 3011818499 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Mighty Oak Medical
    Registration Number
    3011818499
    FEI Number
    3011818499
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    750 W Hampden Ave Ste 120
    City
    Englewood
    State
    CO
    ZIP
    80110
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162419

    Owner / Operator

    Firm Name
    Mighty Oak Medical
    Operator Number
    10050926
    Address
    750 W. Hampden, Suite 120
    City
    Englewood
    State
    CO
    Postal Code
    80110
    Country
    US
    Correspondent
    Mark A Wylie

    Products

    Device Name Product Code
    Pedicle Screw Placement Guide PQC

    Proprietary Names

    FIREFLY Pedicle Screw Navigation Guide

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device