BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    OptiVu™ ROSA® MxR

    Reg #: 9617840 · FEI: 3003714383 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ZIMMER CAS
    Registration Number
    9617840
    FEI Number
    3003714383
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    75 QUEEN ST., SUITE 3300
    City
    MONTREAL, QUEBEC
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K220733

    Owner / Operator

    Firm Name
    ZIMMER, INC.
    Operator Number
    1822565
    Address
    345 E. Main Street, --
    City
    Warsaw
    State
    IN
    Postal Code
    46580
    Country
    US

    US Agent

    Business Name
    Zimmer Biomet
    Contact Name
    Holly Seppanen
    Address
    1800 West Center Street
    City
    Warsaw
    State
    IN
    ZIP
    46580
    Country
    US
    Email
    [email protected]
    Phone
    952 8470494

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    OptiVu™ ROSA® MxR OptiVu™ ROSA® Mixed Reality

    Establishment Types

    Manufacture Medical Device