BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Pantheon Proximal Femur Reconstruction (PFR) System

    Reg #: 3036773273 · FEI: 3036773273 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Adler Ortho SpA
    Registration Number
    3036773273
    FEI Number
    3036773273
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Viale Trento 115/117
    City
    Mezzolombardo Trento
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K241059

    Owner / Operator

    Firm Name
    Adler Ortho S.p.A.
    Operator Number
    10086224
    Address
    Via Dell'Innovazione 9
    City
    Cormano
    State
    Milano
    Postal Code
    20032
    Country
    IT
    Correspondent
    Edgardo Cremascoli

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH

    Proprietary Names

    Pantheon Proximal Femur Reconstruction (PFR) System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)