BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Avalign Delivery Systems does not manufacture drills, burrs, and trephines. This listing has been made

    Reg #: 1835444 · FEI: 3000717687 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Avalign Delivery Systems Division
    Registration Number
    1835444
    FEI Number
    3000717687
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2121 SOUTHTECH DRIVE, SUITE 600
    City
    Greenwood
    State
    IN
    ZIP
    46143
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182436

    Owner / Operator

    Firm Name
    Avalign Delivery Systems Division
    Operator Number
    9026184
    Address
    2121 Southtech Drive, Suite 600
    City
    Greenwood
    State
    IN
    Postal Code
    46143
    Country
    US
    Correspondent
    Thomas Clyne

    Products

    Device Name Product Code
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE

    Proprietary Names

    Avalign Delivery Systems does not manufacture drills, burrs, and trephines. This listing has been made because Medtronic cases and trays are registered as accessories to the drills, burrs, and trephines in K182436

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)