LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K972961
    Device Name
    STELKAST BIPOLAR SYSTEM
    Manufacturer
    STELKAST COMPANY
    Date Cleared
    1997-11-04

    (85 days)

    Product Code
    JDI,KWY
    Regulation Number
    888.3350
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    STELKAST BIPOLAR SYSTEM

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

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) notification for the "Skelkast Bipolar System" (K972961) does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

    This document is a letter from the FDA stating that the device has been determined to be substantially equivalent to a legally marketed predicate device and can therefore be marketed. It lists the indications for use but does not detail any performance metrics, study design, or results that you have requested.

    Therefore, I cannot provide the information requested in your prompt based on the input text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1