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510(k) Data Aggregation

    K Number
    K070794
    Device Name
    ATLANTIK
    Manufacturer
    Date Cleared
    2007-07-10

    (110 days)

    Product Code
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL BIOMAT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ATLANTIK™ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. ATLANTIK™ is a bone void filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended.
    Device Description
    ATLANTIK™ is a synthetic and osteoconductive bone void filler. It is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 70% hydroxyapatite (FIA) and 30% beta-tricalcium phosphate (TCP). Its porosity is interconnected and opened with a total volume ratio of 70%. ATLANTIK™ is available in the form of irregular-shaped vial-packed granules of different sizes and blocks with various shapes and sizes. ATLANTIK TM is provided sterile for single use.
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