BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    ARVIS Surgical Navigation System

    Reg #: 3013552417 · FEI: 3013552417 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    KICO KNEE INNOVATION COMPANY
    Registration Number
    3013552417
    FEI Number
    3013552417
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit 1, 25 Frenchs Forest Rd E
    City
    Frenchs Forest New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K203115

    Owner / Operator

    Firm Name
    Kico Knee Innovation Company
    Operator Number
    10054916
    Address
    Unit 1, 25 Frenchs Forest Rd E
    City
    Frenchs Forest
    State
    New South Wales
    Postal Code
    2086
    Country
    AU
    Correspondent
    Danyon Munro

    US Agent

    Business Name
    Encore Medical, L.P.
    Contact Name
    Sherri Mellingen
    Address
    9800 Metric BLVD
    City
    Austin
    State
    TX
    ZIP
    78758
    Country
    US
    Email
    [email protected]
    Phone
    952 9136383

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    ARVIS Surgical Navigation System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device