BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    PRIMA Humeral System; PRIMA TT Glenoid

    Reg #: 3013791180 · FEI: 3013791180 · Expires 2025
    View on FDA
    Products
    6
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    OEB S.R.L.
    Registration Number
    3013791180
    FEI Number
    3013791180
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Circonvallazione, 9
    City
    Camposanto Modena
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K233712

    Owner / Operator

    Firm Name
    OEB S.r.l.
    Operator Number
    10092438
    Address
    Via Circonvallazione, 9
    City
    Camposanto
    State
    Modena
    Postal Code
    41031
    Country
    IT
    Correspondent
    Andrea Dondi

    Products

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

    Proprietary Names

    PRIMA Humeral System; PRIMA TT Glenoid

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)