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510(k) Data Aggregation

    K Number
    K070864
    Device Name
    BONEPLAST QS CALCIUM SULFATE BONE VOID FILLER
    Date Cleared
    2007-06-01

    (65 days)

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

    BIOMET OSTEOBIOLOGICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BonePlast® QS Bone Void Filler is indicated to be injected into open voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. BonePlast® QS Bone Void Filler is indicated only for bone voids or gaps that are not intrinsic to the bone structure (i.e., the extremities, spine and pelvis). The device is limited to be used in posterolateral spinal fusion procedures only.
    Device Description
    BonePlast OS Bone void filler is a sterile calcium suffate powder, which is supplied dry. When mixed with sterile setting solution intra-operatively, it becomes an injectable filling material for use in non-load bearing procedures. The filler is biogradable and resorbs in approximately eight to twelve weeks, depending on the defect size, based on animal studies.
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