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510(k) Data Aggregation

    K Number
    K051775
    Device Name
    OSTEOMIMETIC SYNTHETIC BONE MATRIX
    Date Cleared
    2005-09-06

    (67 days)

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

    BIOMIMETIC PHARMACEUTICALS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    OsteoMimetic™ Synthetic Bone Matrix is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. The OsteoMimetic matrix is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone in conjunction with standard measures.
    Device Description
    OsteoMimetic Synthetic Bone Matrix is a synthetic, multicrystalline, porous form of ß-tricalcium phosphate [Cas(PO4)2]. The matrix physically fills bone defects to prevent the collapse of soft tissue and stabilize the blood clot. It provides a biocompatible, osteoconductive, and three-dimensional scaffold to facilitate new bone formation. As the matrix is resorbed, bone and other connective tissues grow into the space previously occupied by the matrix. OsteoMimetic Synthetic Bone Matrix is provided sterile as 1-2mm particles.
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