LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K110554
    Device Name
    BIOCERAMIC ORBITAL IMPLANT, ORBTEX
    Manufacturer
    CERAMISYS LTD.
    Date Cleared
    2011-11-02

    (247 days)

    Product Code
    HPZ
    Regulation Number
    886.3320
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BIOCERAMIC ORBITAL IMPLANT, ORBTEX

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

    Ceramisys synthetic orbital implants of either hydroxyapatite or alumina oxide (alumina) are indicated for orbital implantation at the time of enucleation or evisceration of the natural eyeball. They may also be indicated for secondary implantation where extrusion, migration or other malfunction of the primary orbital implant has occurred.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding "Ceramisys Synthetic Orbital Implants." It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance metrics.

    The letter is an administrative notice approving the device for marketing and mentions the indications for use, but it does not include data from performance studies. Therefore, I cannot provide the requested information based on the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1