BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NBX - Non Bridging External Fixator - Hand

    Reg #: 3005893246 · FEI: 3005893246 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    NUTEK Orthopaedics, Inc
    Registration Number
    3005893246
    FEI Number
    3005893246
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    641 SW 3rd Ave
    City
    Fort Lauderdale
    State
    FL
    ZIP
    33315
    Country
    US

    Regulatory Submissions

    510(k) Number
    K122777

    Owner / Operator

    Firm Name
    NUTEK ORTHOPAEDICS, INC.
    Operator Number
    9091870
    Address
    641 SW 3rd Ave, --
    City
    Fort Lauderdale
    State
    FL
    Postal Code
    33315
    Country
    US
    Correspondent
    PETER J MINCIELI

    Products

    Device Name Product Code
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Component, Traction, Invasive JEC

    Proprietary Names

    NBX - Non Bridging External Fixator - Hand

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility