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510(k) Data Aggregation

    K Number
    K063719
    Device Name
    ARTHREX CROSSPIN, MODEL AR-1964P
    Manufacturer
    ARTHREX, INC.
    Date Cleared
    2007-03-06

    (81 days)

    Product Code
    HTY,HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K010633
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Arthrex CrossPin™ is intended to be used for tibial fixation of autograft or allograft ACL soft tissue grafts.

    Device Description

    The Arthrex CrossPin™ is a sterile, disposable device designed for single patient use only. The Cross Pin™ is constructed of an enhanced polymer, Poly(Llactide) or PLLA.

    AI/ML Overview

    The submitted text is a 510(k) summary for the Arthrex CrossPin™, a medical device used for tibial fixation of ACL soft tissue grafts. This document describes the device, its intended use, and its substantial equivalence to a predicate device.

    However, the provided text does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory submission focused on demonstrating substantial equivalence to a legally marketed predicate device, not on presenting performance data against specific acceptance criteria.

    Therefore, I cannot populate the requested table and information points as they are entirely absent from the provided text. The document is an FDA 510(k) summary, which typically focuses on regulatory pathways and substantial equivalence rather than detailed performance studies and acceptance criteria as would be found in a clinical trial report or a comprehensive technical report.

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