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510(k) Data Aggregation

    K Number
    K062857
    Device Name
    KLS MARTIN QUICK DISC
    Manufacturer
    KLS MARTIN L.P.
    Date Cleared
    2006-11-22

    (58 days)

    Product Code
    GXN
    Regulation Number
    882.5330
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    K040864,K031034,K022277,K991860,K972332
    Why did this record match?
    Reference Devices :

    K040864, K031034, K022277, K991860, K972332

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

    The KLS Martin Quick Disc is intended for use in the reattachment of cranial bone flaps after a craniotomy, covering burr holes, and fixation of cranial fractures.

    Device Description

    The KLS Martin Quick Disc is a two-sided cranial closure device. The lower disc is attached to a threaded post. The upper disc is threaded down and locked on the post securely holding the bone flap in place. The KLS Martin Quick Disc diameters range from 12mm to 22mm in size

    AI/ML Overview

    The provided text is a 510(k) summary for the KLS Martin Quick Disc, a cranial closure device. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, clinical studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt for evaluating device performance.

    Therefore, I cannot provide the requested table and detailed study information because the source document does not contain this data. The 510(k) summary is focused on establishing substantial equivalence based on intended use, material composition, and principle of operation, rather than presenting performance data from specific studies with acceptance criteria.

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