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510(k) Data Aggregation

    K Number
    K111069
    Device Name
    OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT
    Manufacturer
    OSTEOSYMBIONICS, LLC
    Date Cleared
    2011-09-22

    (157 days)

    Product Code
    MNF
    Regulation Number
    878.3550
    Why did this record match?
    Product Code :

    MNF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OsteoSymbionics ST Temporalis Implant is indicated to correct temporal hollowing in patients who have had surgery involving the pterional / lateral approach to the cranium, including pterional / lateral craniotomy or decompressive craniectomy. The OsteoSymbionics ST Temporalis Implant augments the space normally occupied by the temporalis muscle. The implant is used for the reconstruction of temporal contour deformities; the reconstruction of temporal defects, and / or the augmentation / reconstruction of the space normally occupied by the temporalis muscle / temporal area (s).
    Device Description
    The OsteoSymbionics Temporal Implants are pre-formed implantable prosthetic implants intended to fill soft-tissue defects in a patient's cranial/craniofacial temporal region. The implants are composed of longterm implantable-grade solid silicone elastomer. The implants are available in left and right, and come in two different sizes, small and medium. The devices are provided sterile, and are attached to native tissue with commercially available suture materials.
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    K Number
    K002586
    Device Name
    MEDPOR PTERIONAL SURGICAL IMPLANT
    Manufacturer
    POREX SURGICAL PRODUCTS GROUP
    Date Cleared
    2000-11-17

    (88 days)

    Product Code
    MNF
    Regulation Number
    878.3550
    Why did this record match?
    Product Code :

    MNF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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