BEUDAMED
    FDA Registration Active 🇺🇸 United States

    2082000400 Rosa Arm Instrument Interface

    Reg #: 2133928 · FEI: 3000717902 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Metal Craft Machine & Engineering, Inc.
    Registration Number
    2133928
    FEI Number
    3000717902
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    13760 Business Center Drive
    City
    Elk River
    State
    MN
    ZIP
    55330
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182964

    Owner / Operator

    Firm Name
    Metal Craft and Riverside Machine & Engineering, Inc.
    Operator Number
    9027247
    Address
    13760 Business Drive, --
    City
    Elk River
    State
    MN
    Postal Code
    55330
    Country
    US
    Correspondent
    Trisha L Mowry

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    2082000400 Rosa Arm Instrument Interface 2082001500 Rosa Arm Reference Frame 2082000200 Rosa Base Reference Frame

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)