LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K981451
    Device Name
    ARGOMEDICAL BIPOLAR SYSTEM
    Manufacturer
    STELKAST COMPANY
    Date Cleared
    1998-08-21

    (121 days)

    Product Code
    KWL
    Regulation Number
    888.3360
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ARGOMEDICAL BIPOLAR SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    1. Fractures of the proximal femur.
    2. Non-unions of proximal femoral neck fractures.
    3. Aseptic necrosis of the femoral head.
    4. Osteo-rheumatoid and post-traumatic arthritis of the hip with minimal distortion of the acetabulum.
    5. Salvage of failed total hip arthroplasty.
    Device Description

    ARGOMEDICAL Biopolar Hip System

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding the substantial equivalence of the ARGOMEDICAL Bipolar Hip System to a predicate device. It does not contain information about acceptance criteria, device performance metrics, study design, or expert adjudication that would be needed to answer your request. Therefore, I cannot generate the requested table and descriptions based on this information.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1