BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Pelvis Belly System

    Reg #: 1526854 · FEI: 1526854 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BIONIX, LLC
    Registration Number
    1526854
    FEI Number
    1526854
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1670 Indianwood Circle
    City
    Maumee
    State
    OH
    ZIP
    43537
    Country
    US

    Regulatory Submissions

    510(k) Number
    K040773

    Owner / Operator

    Firm Name
    BIONIX, LLC
    Operator Number
    1526854
    Address
    1670 Indian Wood Circle, --
    City
    Maumee
    State
    OH
    Postal Code
    43537
    Country
    US
    Correspondent
    Joshua A Ball

    Products

    Device Name Product Code
    Accelerator, Linear, Medical IYE

    Proprietary Names

    Pelvis Belly System T-Form SecureVac Box Adaptor SecureFoam System SecureVac Systems

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device