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510(k) Data Aggregation

    K Number
    K022853
    Device Name
    ENDOTACK
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    2002-11-25

    (90 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ENDOTACK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Endotack is intended for use to provide tibial fixation for surgical correction of cruciate ligament ruptures as well as for cruciate ligament implant replacement.

    Device Description

    The Endotack is a button fixation device. The body contact portions of the Endotack are composed of titanium, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) summary and FDA clearance letter for a medical device called "Endotack," a suture anchor. It describes the device, its intended use, and its substantial equivalence to a predicate device, but it does not include details on performance testing, acceptance criteria, or study methodologies.

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