BEUDAMED
    FDA Registration Active 🇧🇷 Brazil

    Small and Large Fragments Osteosynthesis System NEOFIX

    Reg #: 3009158523 · FEI: 3009158523 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    NEOORTHO PRODUTOS ORTOPEDICOS S/A
    Registration Number
    3009158523
    FEI Number
    3009158523
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Rua Angelo Domingos Durigan, 607, Cascatinha
    City
    Curitiba Parana
    Country
    BR

    Regulatory Submissions

    510(k) Number
    K113733

    Owner / Operator

    Firm Name
    NEOORTHO Produtos Ortopedicos S/A
    Operator Number
    10036684
    Address
    Rua Angelo Domingos Durigan, 607, Cascatinha
    City
    Curitiba
    State
    Parana
    Postal Code
    82025-100
    Country
    BR

    US Agent

    Business Name
    PaxMed International LLC
    Contact Name
    Floyd Larson
    Address
    1925 Palomar Oaks Way Ste 210
    City
    Carlsbad
    State
    CA
    ZIP
    92008
    Country
    US
    Email
    [email protected]
    Phone
    858 7921235

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS

    Proprietary Names

    Small and Large Fragments Osteosynthesis System NEOFIX

    Establishment Types

    Manufacture Medical Device