BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    H-Max S femoral stems

    Reg #: 3026771806 · FEI: 3026771806 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    STI LUALDI S.R.L.
    Registration Number
    3026771806
    FEI Number
    3026771806
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via del Molino 36
    City
    Casiacco Pordenone
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K112091

    Owner / Operator

    Firm Name
    STI Lualdi S.r.l.
    Operator Number
    10092679
    Address
    Via del Molino 36
    City
    Casiacco
    State
    Pordenone
    Postal Code
    33090
    Country
    IT
    Correspondent
    Anna Gerometta

    Products

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

    Proprietary Names

    H-Max S femoral stems

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)