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510(k) Data Aggregation

    K Number
    K071912
    Device Name
    APACERAM BONE GRAFT SUBSTITUTE
    Manufacturer
    PENTAX CORP.
    Date Cleared
    2007-10-29

    (110 days)

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

    PENTAX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Apaceram™ Bone Graft Substitute is a synthetic hydroxyapatite provided in several particulate and shaped sizes. It is intended for use as a bone void filler for bony voids, gaps, or defects that are not intrinsic to the stability of the bony structure. Apaceram ™ is intended to be placed into bony voids or gaps of the skeletal system (i.e. extremities, spine, or pelvis) caused by degeneration, trauma or surgery. It also can be used with autograft as a bone graft extender. Apaceram™ is resorbed and replaced with bone during the healing process.
    Device Description
    Apaceram ™ is a hydroxyapatite osteoconductive bone void filler. It is available in four types: AX, B, G, and R, which vary in porosity, shape and sizes. Apaceram ™ is provided sterile for single patient use.
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