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510(k) Data Aggregation

    K Number
    K040612

    Validate with FDA (Live)

    Device Name
    SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
    Manufacturer
    DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
    Date Cleared
    2004-06-17

    (101 days)

    Product Code
    HRX,HXG
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K032358,K034037
    Predicate For
    K053336
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SKy Bone Expander System is intended for use as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine; hand, tibia; radius and calcaneus. In the spine, it may be used in combination with polymethylmethacrylate (PMMA) bone cernents that are legally marketed for use in vertebroplasty or kyphoplasty procedures.

    Device Description

    The SKy System consists of the following components:

    • Expandable tube a tube-like component, mounted on a delivery system. Inserted into the bone in reduced 5-mm diameter configuration and expanded within the bone.
    • Delivery system used for the insertion, expansion, and retrieval of the expandable tube.
    • Instrumentation Set - a set of accessories to assist in insertion and location of the device.
    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) summary for the SKy Bone Expander System, outlining its intended use, description, and substantial equivalence to previously cleared devices. It does not include details about performance testing, sample sizes, ground truth establishment, or clinical studies.

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