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510(k) Data Aggregation

    K Number
    K142463
    Device Name
    Bio2 CLM BG Bioactive Scaffold
    Date Cleared
    2014-12-18

    (107 days)

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

    Bio2 Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bio2 CLM-BG Bioactive Scaffold is intended for use as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. Bio2 CL.M+BG Bioacive Scaffold is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. extremitics 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
    The Bio2 Technologies implants are bone void fillers in the shape of cylinders, blocks and wedges. The devices are osteoconductive, bioactive, bone void fillers. The implants are made from a fiber based bioactive glass. The device structure allows tissue infiltration between the bioactive glass fibers. The fibers then are slowly absorbed and replaced by new bone tissue during the healing process. The cylinders, blocks and wedges are provided sterile and are intended for single use.
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