BEUDAMED
    FDA Registration Active 🇺🇸 United States

    M-Vizion Monobloc

    Reg #: 3006639916 · FEI: 3006639916 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Medacta USA, Inc.
    Registration Number
    3006639916
    FEI Number
    3006639916
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    6386 Global Drive, Suite 101
    City
    Memphis
    State
    TN
    ZIP
    38141
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212327

    Owner / Operator

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

    Products

    Device Name Product Code
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO

    Proprietary Names

    M-Vizion Monobloc

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198