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

    ORBITAL RECONSTRUCTIVE IMPLANT II

    K Number: K083342 · Decision Mar 12, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    38
    Applicant Total
    2
    Review Days
    120

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    Basic Information

    Device Name
    ORBITAL RECONSTRUCTIVE IMPLANT II
    K Number
    K083342
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3320
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Evera Medical, Inc.
    Date Received
    November 12, 2008
    Decision Date
    March 12, 2009
    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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