BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Revival Modular Hip Stem

    Reg #: 3007391088 · FEI: 3007391088 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    GRUPPO BIOIMPIANTI S.R.L.
    Registration Number
    3007391088
    FEI Number
    3007391088
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Liguria 28
    City
    Peschiera Borromeo Milano
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K191374

    Owner / Operator

    Firm Name
    Gruppo Bioimpianti S.r.l.
    Operator Number
    10051817
    Address
    Via Liguria 28
    City
    Peschiera Borromeo
    State
    Milano
    Postal Code
    20068
    Country
    IT
    Correspondent
    Lucinda Gerber

    US Agent

    Business Name
    OMNIlifeScience, Inc.
    Contact Name
    Lucinda Gerber
    Address
    480 Paramount Dr
    City
    Raynham
    State
    MA
    ZIP
    02767
    Country
    US
    Email
    [email protected]
    Phone
    772 3212478

    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

    Revival Modular Hip Stem

    Establishment Types

    Manufacture Medical Device