LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K252826

    Validate with FDA (Live)

    Device Name
    ARIX Femur Nail System
    Manufacturer
    Jeil Medical Corporation
    Date Cleared
    2025-12-10

    (96 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K200869
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ARIX Femur Nail System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone).

    Device Description

    Anti-Rotation Lag Screw and Telescopic Lag Screw in ARIX Femur Nail System are made of Titanium Alloy which meets ASTM F136 and only 'Anti-Rotation Pin' section of Anti-Rotation Lag Screw is made of Nickel-Titanium Alloy which meets ASTM F2063. ARIX Femur Nail System is provided Sterile or Non-Sterile.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1