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510(k) Data Aggregation

    K Number
    K972735
    Device Name
    TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP)
    Manufacturer
    MEDNET LOCATOR, INC.
    Date Cleared
    1997-09-05

    (45 days)

    Product Code
    ETA
    Regulation Number
    874.3495
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP)

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

    The MedNet LocaTOR, INC., Total Ossicular Replacement Prosthesis (TORP) is to be used by ear, nose and throat physicians to restore the hearing mechanism related to loss or destruction or damage to the ear ossicles due to prolonged chronic infection.

    Device Description

    Total Ossicular Replacement Prosthesis (TORP)

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a Total Ossicular Replacement Prosthesis (TORP). It is a regulatory document, not a study report or a technical performance document. Therefore, it does not contain any of the requested information regarding acceptance criteria, device performance, study details, or ground truth establishment.

    The letter primarily states that the device is substantially equivalent to legally marketed predicate devices, allowing its manufacturer, MedNet Locator, Inc., to market it. It also outlines the general regulatory requirements the device must meet.

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