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510(k) Data Aggregation

    K Number
    K091234
    Device Name
    SKELTEX ISV
    Manufacturer
    SKELTEX TECHNOLOGIES, INC.
    Date Cleared
    2010-02-16

    (295 days)

    Product Code
    NDN,KIH
    Regulation Number
    888.3027
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Skeltex ISV is intended for percutaneous delivery of PMMA bone cement in vertebroplasty or kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but the provided text is a 510(k) summary letter from the FDA regarding a medical device called "Skeltex ISV," which is a PMMA bone cement. This document describes the FDA's substantial equivalence determination for this device, its intended use, and regulatory information.

    However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or any of the other specific study details you've requested.

    Therefore, I cannot fulfill your request using the provided text. To answer your questions, I would need a different document, such as a clinical study report, a scientific paper, or a more detailed technical document accompanying the 510(k) submission that describes the validation and testing of the device.

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