BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SPIWay

    Reg #: 3010880816 · FEI: 3010880816 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SPIWay, LLC
    Registration Number
    3010880816
    FEI Number
    3010880816
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3600 Corte Castillo
    City
    Carlsbad
    State
    CA
    ZIP
    92009
    Country
    US

    Regulatory Submissions

    510(k) Number
    K153686

    Owner / Operator

    Firm Name
    SPIWay, LLC
    Operator Number
    10046778
    Address
    3600 Corte Castillo
    City
    Carlsbad
    State
    CA
    Postal Code
    92009
    Country
    US
    Correspondent
    Elaine Tronic

    Products

    Device Name Product Code
    Splint, Intranasal Septal LYA

    Proprietary Names

    SPIWay

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility