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510(k) Data Aggregation

    K Number
    K123764
    Device Name
    DURETTE OCULAR IMPLANT
    Manufacturer
    OCULO-PLASTIK, INC.
    Date Cleared
    2013-01-31

    (55 days)

    Product Code
    HPZ, EST
    Regulation Number
    886.3320
    Why did this record match?
    Applicant Name (Manufacturer) :

    OCULO-PLASTIK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Durette ocular acrylic (PMMA) implants in 4 models are permanent implants that occupy the eye cavity when it becomes necessary to surgically remove the eye (enucleation), the contents of the eye sac (evisceration), or space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and to impart motion and stability to the eventual ocular prosthesis.
    Device Description
    The Durette implant is a quasi-spherical ocular implant made in 4 models for variations in anterior surface. Each has a permanent smooth surface and many tunnels to allow direct suturing of the muscles. These 20 interconnected tunnels, all situated in the anterior 3rd of the implant, allow tissue integration or ingrowth to help stabilize the implant. Each has an off-center elongation.
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