BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ONX Large External Fixation System

    Reg #: 3015946784 · FEI: 3015946784 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ORTHONOVIS, INC.
    Registration Number
    3015946784
    FEI Number
    3015946784
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 Hargrove Grade, 2F
    City
    Palm Coast
    State
    FL
    ZIP
    32137
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213905

    Owner / Operator

    Firm Name
    OrthoNovis, Inc.
    Operator Number
    10061543
    Address
    1 Hargrove Grade, 2F
    City
    Palm Coast
    State
    FL
    Postal Code
    32137
    Country
    US
    Correspondent
    Ken West

    Products

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

    Proprietary Names

    ONX Large External Fixation System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device