BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    AMIStem and Quadra - Line Extension

    Reg #: 3008110533 · FEI: 3008110533 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MEDACTA INTERNATIONAL SA
    Registration Number
    3008110533
    FEI Number
    3008110533
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Alla Rossa 6
    City
    Rancate Ticino
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K121011

    Owner / Operator

    Firm Name
    Medacta International SA
    Operator Number
    10024526
    Address
    Strada Regina
    City
    Castel San Pietro
    State
    Ticino
    Postal Code
    6874
    Country
    CH
    Correspondent
    Stefano Baj

    US Agent

    Business Name
    Medacta USA
    Contact Name
    Christopher Lussier
    Address
    6386 Global Drive, Suite 101
    City
    Memphis
    State
    TN
    ZIP
    38141
    Country
    US
    Email
    [email protected]
    Phone
    901 2033470

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO

    Proprietary Names

    AMIStem and Quadra - Line Extension

    Establishment Types

    Manufacture Medical Device