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510(k) Data Aggregation

    K Number
    K991029
    Device Name
    RAPIDFLAP CRANIAL CLAMP
    Manufacturer
    WALTER LORENZ SURGICAL, INC.
    Date Cleared
    1999-04-23

    (25 days)

    Product Code
    GXN
    Regulation Number
    882.5330
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    K971252
    Why did this record match?
    Device Name :

    RAPIDFLAP CRANIAL CLAMP

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

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

    Device Description

    The modification to the SCC-100 device are as follows:

    1. Attachment of upper and lower plates: Modified RapidFlap device has a grooved post connection between the upper and lower plates.
    2. The material: Modified RapidFlap device is manufactured from titanium 6 Al 4 V alloy.
    3. Sterility: Modified RapidFlap device will be marketed sterile.
    4. Drawings for necessary instrumentation changes for application of modified device is included in Attachment I.
    AI/ML Overview

    The provided text is a 510(k) summary for the RapidFlap Cranial Clamp, a medical device. It describes the device, its intended use, modifications from a predicate device, and potential risks. However, the document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

    Therefore, I cannot provide the requested information. The document focuses on the regulatory aspects of device modification and substantial equivalence, not on performance studies or acceptance criteria.

    To answer your questions, I would need a different type of document, such as a clinical study report, a verification and validation report, or a performance testing summary.

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