BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    SMR Glenosphere Dia. 42

    Reg #: 3026771806 · FEI: 3026771806 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    5

    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
    K212800

    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, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented PAO
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Shoulder Prosthesis, Reverse Configuration PHX

    Proprietary Names

    SMR Glenosphere Dia. 42 PRIMA Humeral System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)