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510(k) Data Aggregation

    K Number
    K972322
    Device Name
    LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES
    Manufacturer
    WALTER LORENZ SURGICAL, INC.
    Date Cleared
    1997-08-18

    (59 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES

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

    Rigid fixation of cranio, facial and neurological bone.

    Device Description

    The titanium bone plates and screws are manufactured in various sizes, with various design features for cranio, facial, and neurological surgical procedures.

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the "Lorenz Sterile Bone Plates and Screws." This document does not describe:

    • Acceptance criteria or device performance data. The letter merely states that the device is substantially equivalent to legally marketed predicate devices.
    • Any specific study details. There is no mention of clinical trials, performance studies, sample sizes, expert involvement, or ground truth methodologies.

    Therefore, I cannot provide the requested information based on the given input. The document is a regulatory approval letter, not a technical report detailing product performance or study design.

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