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510(k) Data Aggregation

    K Number
    K982906
    Device Name
    LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM
    Manufacturer
    WALTER LORENZ SURGICAL, INC.
    Date Cleared
    1998-11-12

    (86 days)

    Product Code
    MQN
    Regulation Number
    872.4760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Lorenz Intraoral Linear Mandibular Distraction System is intended for use in the gradual bone lengthening of the mandible as mandibular deficiencies or post traumatic defects require gradual bone distraction.

    Device Description

    Lorenz Intraoral Linear Mandibular Distraction System

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter from the FDA for the "Lorenz Intraoral Linear Mandibular Distraction System". This document does not contain information about acceptance criteria, device performance studies, sample sizes, or ground truth establishment for an AI/ML powered medical device.

    The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...". This indicates a traditional medical device approval based on substantial equivalence to a predicate device, not an AI/ML driven device that would typically involve performance studies as outlined in your request.

    Therefore, I cannot provide the requested information based on the provided text.

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