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510(k) Data Aggregation

    K Number
    K984550
    Device Name
    PRE-THREADED ENDOBUTTON
    Manufacturer
    SMITH & NEPHEW, INC.
    Date Cleared
    1999-03-01

    (69 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K933948,K952535,K980155
    Why did this record match?
    Device Name :

    PRE-THREADED ENDOBUTTON

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

    The Pre-Threaded EndoButton is intended to be used to fixate suture during the repair of tendon and ligament fixation. The Pre-Threaded EndoButton is used for fixation of tendons and ligaments during orthopedic reconstructive procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

    Device Description

    The Pre-Threaded EndoButton is a titanium suture retention device packaged sterile, pre-threaded with polyester tape and polyester suture. The construct is used to fixate tendons and ligaments during orthopedic procedures, specifically during ACL reconstructions.

    AI/ML Overview

    This document is a 510(k) summary for the Pre-Threaded EndoButton and does not contain information about acceptance criteria or a study proving its performance. The document focuses on demonstrating substantial equivalence to previously cleared devices.

    Therefore, I cannot provide a response to your request as the necessary information is not present in the provided text.

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