BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Mighty Oak Medical

    Reg #: 3011818499 · FEI: 3011818499 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Mighty Oak Medical
    Registration Number
    3011818499
    FEI Number
    3011818499
    Status
    Active
    Expiry Year
    2026
    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
    Orthosis, Spinal Pedicle Fixation MNI
    Posterior Cervical Screw Placement Guide QSD

    Proprietary Names

    FIREFLY Pedicle Screw Navigation Guide FIREFLY FIREFLY® Cervical Navigation Guide Midline Navigation Screw Guide Pedicle screw placement guide

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device