BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Augment Reamer Guide Inserter

    Reg #: 3011015572 · FEI: 3011015572 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    INCIPIO DEVICES
    Registration Number
    3011015572
    FEI Number
    3011015572
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3650 West 200 North
    City
    Huntington
    State
    IN
    ZIP
    46750
    Country
    US

    Regulatory Submissions

    510(k) Number
    K193180

    Owner / Operator

    Firm Name
    Incipio Devices
    Operator Number
    10047511
    Address
    3650 W 200 N
    City
    Huntington
    State
    IN
    Postal Code
    46750
    Country
    US
    Correspondent
    Troy Johnson

    Products

    Device Name Product Code
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS

    Proprietary Names

    Augment Reamer Guide Inserter

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)