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    K Number
    K083342
    Device Name
    ORBITAL RECONSTRUCTIVE IMPLANT II
    Manufacturer
    EVERA MEDICAL, INC.
    Date Cleared
    2009-03-12

    (120 days)

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

    EVERA MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ORI II is intended for augmentation or restoration in the craniofacial region. The Orbital Reconstructive Implant II is indicated as an implant for augmentation, reconstruction, or restoration in and around the orbit of the eye, such as in reconstruction following orbital trauma or tumor excision, to treat orbital volume deficiencies, or in the correction of enophthalmos.
    Device Description
    The Orbital Reconstructive Implant II (ORI II) is a non-absorbable, inert, sterile, porous, implant composed of porous silicone elastomer and expanded polytetrafluoroethylene (ePTFE). This polymeric implant is available in a range of lengths and widths to accommodate the surgical application and the needs of the individual surgeon practicing medicine.
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    K Number
    K063154
    Device Name
    FACIAL RECONSTRUCTIVE MESH (FRM)
    Manufacturer
    EVERA MEDICAL, INC.
    Date Cleared
    2007-07-10

    (267 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    EVERA MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Facial Reconstructive Mesh is intended for use in plastic and reconstructive surgery of the face and head to provide soft tissue repair or reinforcement.
    Device Description
    The FRM is a non-absorbable, inert, sterile, porous, surgical mesh composed of reinforcing woven polyester fabric, silicone elastomer and expanded polytetrafluoroethylene (ePTFE). This polymeric mesh is available in a range of lengths and widths to accommodate the surgical application.
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