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510(k) Data Aggregation

    K Number
    K231905
    Device Name
    Electro-Spec Steri-Caps
    Manufacturer
    Electro-Spec, Inc
    Date Cleared
    2023-08-14

    (46 days)

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

    Electro-Spec, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electro-Spec Steri-Caps are indicated for use in protection of protruding ends of wires. Examples of procedures that may leave protruding wires include: - Osteotomies or arthrodesis of fractures management in the foot or hand - Fixation of small bone fragments, in long bones or small bones fractures
    Device Description
    The Electro-Spec Steri-Caps are indicated for use in protection of protruding ends of wires. Examples of procedures that may leave protruding wires include: - Osteotomies or arthrodesis of fractures management in the foot or hand - Fixation of small bone fragments, in long bones or small bones fractures- Fixation of small bone fragments, in long bones or small bones fractures Steri-Caps are comprised of a pin ball intended to be placed on the end of a wire or pin protruding from bone, secured with a setscrew, and used to protect the user and wire. The pin balls are offered in diameters of 8.95mm and 12.13mm, and designed to accommodate K-wires or pins less than 1.65mm in diameter. The set screws are offered in lengths of 3.30mm. The longer of the set screws is referred to as the Long Set Screw. Each set screw is threaded with an M4 x 0.7 outer thread, and has a 2.50mm diameter hexagonal cannulation for use with the 2.5mm driver. The 2.5mm driver is used to set the set screw once the pin or wire has been placed through the pin ball. Each pin ball and set screw is offerent materials, namely 6A4V ELI Titanium per ASTM F136, 304 SST, or 17-4 SST, Heat Treat to condition H900. The component is then treated with an ES (Electro-Spec) Surface Treatment, intended to add hardness, scratch resistance, hydrophobicity, and wear resistance. The ES Surface Treatment is a 4-to-15-micron thick, electroplated alloy that can be plated on numerous types of surfaces providing better scratch-resistance, corrosion, and tarnish properties than conventional surfaces can provide due to its hardness and hydrophobic properties. A satin finish is provided on all components. All components and the instrument are offered non-sterilization before use
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