BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VTI InterLink™ Pedicle Screw System

    Reg #: 3008959459 · FEI: 3008959459 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    3

    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
    K110046

    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
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH

    Proprietary Names

    VTI InterLink™ Pedicle Screw System Athena Pedicle Screw System Opus Medical Capella Pedicle Screw System Agoge Pedicle Screw System Royal Oak Pedicle Screw System

    Establishment Types

    Manufacture Medical Device