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510(k) Data Aggregation

    K Number
    K070220
    Device Name
    OSTEOFIX BONE VOID FILLER
    Manufacturer
    CALCITEC, INC
    Date Cleared
    2007-04-12

    (79 days)

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

    CALCITEC, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Osteofix™ Bone Void Filler is indicated for use to fill bony voids or gaps that are not intrinsic to the stability of the bony structure. Osteofix™ Bone Void Filler is intended to be injected into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a Bone Void Filler that resorbs and is replaced with bone during the healing process.
    Device Description
    Osteofix™ Bone Void Filler is a synthetic, injectable, resorbable, Bone Void Filler.
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