BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Opus Medical Gemini IBFD System

    Reg #: 3008959459 · FEI: 3008959459 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ROMD, LLC
    Registration Number
    3008959459
    FEI Number
    3008959459
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2967 Waterview Drive
    City
    Rochester Hills
    State
    MI
    ZIP
    48309
    Country
    US

    Regulatory Submissions

    510(k) Number
    K110177

    Owner / Operator

    Firm Name
    Royal Oak Medical Devices
    Operator Number
    10036878
    Address
    2967 Waterview Drive
    City
    Rochester Hills
    State
    MI
    Postal Code
    48309
    Country
    US
    Correspondent
    David A Zagorowski

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX

    Proprietary Names

    Opus Medical Gemini IBFD System Helena IBFD System Hippeis IBFD System Royal Oak IBFD System

    Establishment Types

    Manufacture Medical Device