BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BIOCERAMIC ORBITAL IMPLANT, ORBTEX

    K Number: K110554 · Decision Nov 2, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    38
    Applicant Total
    2
    Review Days
    247

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    Basic Information

    Device Name
    BIOCERAMIC ORBITAL IMPLANT, ORBTEX
    K Number
    K110554
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3320
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ceramisys, Ltd.
    Date Received
    February 28, 2011
    Decision Date
    November 2, 2011
    Product Code
    HPZ
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HPZ Implant, Eye Sphere

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    Other Clearances by Ceramisys, Ltd.

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