BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)

    Reg #: 3015338559 · FEI: 3015338559 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    AMDT HOLDINGS, INC.
    Registration Number
    3015338559
    FEI Number
    3015338559
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    328 Poplar View Lane East, Suite 2
    City
    Collierville
    State
    TN
    ZIP
    38017
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190069

    Owner / Operator

    Firm Name
    ARTHREX, INC.
    Operator Number
    1220287
    Address
    1370 CREEKSIDE BLVD., --
    City
    Naples
    State
    FL
    Postal Code
    34108
    Country
    US
    Correspondent
    Barry Dietz

    Products

    Device Name Product Code
    Pin, Fixation, Smooth HTY
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Software For Diagnosis/Treatment OSN

    Proprietary Names

    SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility