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510(k) Data Aggregation

    K Number
    K120602
    Device Name
    APACERAM BONE GRAFT SUBSTITUTE
    Manufacturer
    Date Cleared
    2012-03-23

    (24 days)

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

    HOYA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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, posterolateral spine, or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. 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. Apaceram™ is composed of calcium salts, is osteoconductive, and provides an interconnected, highly porous scaffold environment for new bone ingrowth.
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