BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Axoguard HA+ Nerve Protector

    Reg #: 3011006318 · FEI: 3011006318 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AxoGen Corporation
    Registration Number
    3011006318
    FEI Number
    3011006318
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    300 Boone Rd Ste A3
    City
    Burleson
    State
    TX
    ZIP
    76028
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223640

    Owner / Operator

    Firm Name
    AxoGen Corporation
    Operator Number
    10031236
    Address
    13631 Progress Blvd, Suite 400
    City
    Alachua
    State
    FL
    Postal Code
    32615
    Country
    US
    Correspondent
    Mark Friedman

    Products

    Device Name Product Code
    Cuff, Nerve JXI

    Proprietary Names

    Axoguard HA+ Nerve Protector

    Establishment Types

    Manufacture Medical Device