BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Apex Femoral Nailing System

    Reg #: 3014976005 · FEI: 3014976005 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    ORTHOXEL
    Registration Number
    3014976005
    FEI Number
    3014976005
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Cube House, Cork Business and Technology Park, Model Farm Road, Bishopstown
    City
    Cork
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K181375

    Owner / Operator

    Firm Name
    OrthoXel
    Operator Number
    10058878
    Address
    Cube House,, Cork Business and Technology Park, Model Farm Road
    City
    Cork
    State
    IE-NOTA
    Postal Code
    T12 H966
    Country
    IE
    Correspondent
    Mark Moynihan

    US Agent

    Business Name
    MCRA, LLC
    Contact Name
    Hollace Rhodes
    Address
    1050 K Street NW, Suite 1000
    City
    Washington
    State
    DC
    ZIP
    20001
    Country
    US
    Email
    [email protected]
    Phone
    202 5525807

    Products

    Device Name Product Code
    Nail, Fixation, Bone JDS
    Rod, Fixation, Intramedullary And Accessories HSB

    Proprietary Names

    Apex Femoral Nailing System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198