BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    ROSA Partial Knee System

    Reg #: 3008738628 · FEI: 3008738628 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Exo-s Saint-Damien Inc.
    Registration Number
    3008738628
    FEI Number
    3008738628
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    22 rue de l'Entreprise
    City
    St-Damien de Buckland Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K071714

    Owner / Operator

    Firm Name
    EXO-S
    Operator Number
    10079113
    Address
    22 rue de l'Entreprise
    City
    St-Damien de Buckland
    State
    Quebec
    Postal Code
    G0R2Y0
    Country
    CA
    Correspondent
    Tammy Thompson

    US Agent

    Business Name
    QUARAS, LLC
    Contact Name
    Roshana Ahmed
    Address
    2101 Camino Rey
    City
    Fullerton
    State
    CA
    ZIP
    92833
    Country
    US
    Email
    [email protected]
    Phone
    657 2487361

    Products

    Device Name Product Code
    Neurological Stereotaxic Instrument HAW

    Proprietary Names

    ROSA Partial Knee System Navitrack-Total Hip Replacement CT-Free Cup ROSA Shoulder System Navitrack OS Knee Universal Navitrack OS Unicond Knee Universal ROSA Knee System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)