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510(k) Data Aggregation

    K Number
    K022827
    Device Name
    ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR
    Manufacturer
    LINVATEC CORP.
    Date Cleared
    2002-11-22

    (88 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    K060714
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Linvatec UltraFix® Knotless MiniMite® Suture Anchor is intended for reattaching soft tissue to glenoid bone in the shoulder. The following are the indications for use: Bankart lesion repairs, SLAP lesion repairs, capsular shift, capsulolabral reconstructions.

    Device Description

    Not Found

    AI/ML Overview

    This document does not contain information about acceptance criteria, device performance, or a study proving the device meets acceptance criteria. The provided text is a 510(k) summary for the UltraFix® Knotless MiniMite® Suture Anchor, which primarily focuses on regulatory approval, device classification, and indications for use, but does not include detailed performance study data.

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