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510(k) Data Aggregation

    K Number
    K093062
    Device Name
    VERTOS MEDICAL MILD DEVICE KIT
    Manufacturer
    X-STEN CORP.
    Date Cleared
    2010-02-04

    (127 days)

    Product Code
    HRX,HAE
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K062038,K062711
    Predicate For
    K122662,K180876,K212636,K233800
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Vertos Medical mild® Device Kit is a set of specialized surgical instruments intended to be used to perform lumbar decompressive procedures for the treatment of various spinal conditions.

    Device Description

    The Vertos Medical mild® Device Kit is a set of specialized arthroscopic surgical instruments. They are supplied sterile, for single use only.

    AI/ML Overview

    The provided text does not describe an AI medical device or a study proving that it meets acceptance criteria. The document is a 510(k) premarket notification for a traditional medical device, the "Vertos Medical mild® Device Kit," which is a set of specialized arthroscopic surgical instruments.

    Therefore, I cannot extract the information required in the requested format as it pertains to AI medical devices and their performance studies. The document only mentions "Biocompatibility evaluation," "Bench testing," and "Cadaveric testing" to demonstrate compliance and substantial equivalence to predicate devices, not AI performance criteria or studies.

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