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510(k) Data Aggregation

    K Number
    K031034
    Device Name
    SPIN DOWN RAPIDFLAP
    Manufacturer
    WALTER LORENZ SURGICAL, INC.
    Date Cleared
    2003-05-21

    (50 days)

    Product Code
    GXN
    Regulation Number
    882.5330
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    K971252,K991029
    Predicate For
    K062857
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Spin Down RapidFlap is indicated for the re-attachment of the bone flap after a craniotomy.

    Device Description
    Spin Down RapidFlapmodificationK971252 SevrainCranial ClampK991029 RapidFlapCranial Clamp
    Attachment ofupper and lowerplatesThreaded stemattachment betweenthe upper and lowerplatesThreaded stemattachment betweenupper and lower platesGrooved postconnection betweenthe upper and lowerplates.
    MaterialCP Titanium andTitanium 6A1 4V alloyCP Titanium, grade 2Titanium 6A1 4V alloy
    SterilitySterileNon-SterileSterile
    AI/ML Overview

    This document describes a medical device modification (Spin Down RapidFlap) and its equivalency to previously cleared devices. It does not contain information about a study proving the device meets acceptance criteria, an AI algorithm, or any associated performance metrics or ground truth establishment.

    Therefore, I cannot fulfill your request as it pertains to acceptance criteria, device performance, AI study details, or ground truth. The provided text is a summary of safety and effectiveness for a 510(k) premarket notification for a traditional medical device (a cranial clamp), focusing on its materials and attachment mechanism compared to predicate devices.

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