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510(k) Data Aggregation

    K Number
    K111018
    Device Name
    POLYFUSE - NEUROBONE
    Manufacturer
    Date Cleared
    2012-02-14

    (308 days)

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

    ATPAC MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    OsteoLaso Granule & Strips are intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoLaso Granule & Strips are indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. OsteoLaso Granule & Strips are intended to be pasked into boney voids or gaps of the skeletal system as a bone void filler (i.e., extremeties, posterolateral spine and pelvis). This product provides a bone void filler that resorbs and is replaced by bone during the healing process.
    Device Description
    OsteoLaso Granule & Strips consists of beta-tricalcium phosphate, and polyphosphate. It is the bone graft substitute that regenerates bone after implantation.
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