BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    SMR Shoulder System

    Reg #: 3027484613 · FEI: 3027484613 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    VALTECNE SPA
    Registration Number
    3027484613
    FEI Number
    3027484613
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via al Campo Sportivo 277
    City
    Berbenno di Valtellina Sondrio
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K161476

    Owner / Operator

    Firm Name
    Valtecne SpA
    Operator Number
    10089402
    Address
    Via al Campo Sportivo 277
    City
    Berbenno di Valtellina
    State
    Sondrio
    Postal Code
    23010
    Country
    IT
    Correspondent
    Adolfo Ottonello

    US Agent

    Business Name
    Peoples & Associates Consulting LLC
    Contact Name
    Stephen Peoples
    Address
    329 Peninsula Drive
    City
    Fort Wayne
    State
    IN
    ZIP
    46814
    Country
    US
    Email
    [email protected]
    Phone
    260 6450327

    Products

    Device Name Product Code
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT

    Proprietary Names

    SMR Shoulder System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)