LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K121004
    Device Name
    APEX KIRSCHNER WIRES AND STEINMANN PINS
    Manufacturer
    APEX TOOLS & ORTHOPEDICS CO.
    Date Cleared
    2012-04-24

    (21 days)

    Product Code
    HTY, JDW
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    **APEX TOOLS **& ORTHOPEDICS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Apex Kirschner Wires and Steinmann Pins are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
    Device Description
    Apex Kirschner Wires and Steinmann Pins are available in several diameters and lengths, in both threaded and non-threaded designs with a variety of point geometries.
    Ask a Question
    K Number
    K112254
    Device Name
    APEX KIRSCHNER WIRES AND STEINMANN PINS
    Manufacturer
    APEX TOOLS & ORTHOPEDICS CO.
    Date Cleared
    2011-10-11

    (67 days)

    Product Code
    HTY, JDW
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    **APEX TOOLS **& ORTHOPEDICS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Apex Kirschner wires and Steinmann pins are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
    Device Description
    Apex Kirschner Wires and Steinmann Pins are available in several diameters and lengths, in both threaded and non-threaded designs with a variety of point geometries.
    Ask a Question

    Page 1 of 1