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510(k) Data Aggregation

    K Number
    K030492
    Device Name
    TITANIUM OSSICULAR REPLACMENT SYSTEM
    Manufacturer
    INVOTEC INTERNATIONAL, INC.
    Date Cleared
    2003-03-03

    (12 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 :

    TITANIUM OSSICULAR REPLACMENT SYSTEM

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

    Reconstruction of the sound conduction chain between the base of stapes and the tympanic membrane level by replacing the missing middle ear bones with a total implant in the sense of a tympanoplasty of type IIIC given an existing intact base of stapes with normal mobility and without luxation.

    Device Description

    Titanium Ossicular Replacement System

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the "Titanium Ossicular Replacement System." It indicates that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance, or any studies conducted.

    Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on detailed performance evaluation against specific criteria or study results.

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