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510(k) Data Aggregation

    K Number
    K041065
    Device Name
    PANALOK RC LOOP ANCHOR
    Manufacturer
    Depuy Mitek
    Date Cleared
    2004-05-07

    (14 days)

    Product Code
    JDR
    Regulation Number
    888.3030
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K002639,K964013
    Predicate For
    K060553
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Mitek Panalok RC Loop Anchor is indicated for use in soft tissue to bone fixation in association with adequate post-operative immobilization as follows: Shoulder: Rotator cuff repair.

    Device Description

    The Panalok RC Loop Anchor System is a preloaded absorbable disposable suture anchor/inserter assembly designed to allow soft tissue repair to bone with enhanced suture-sliding capabilities. The absorbable anchor is a one-piece suture anchor constructed of molded Poly(L-lactide) polymer.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

    The document is a 510(k) summary for the Panalok RC Loop Anchor, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance studies against specific acceptance criteria.

    Therefore, I cannot fulfill your request with the given input.

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