Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K102208
    Device Name
    NANOGEN
    Manufacturer
    Date Cleared
    2011-05-06

    (274 days)

    Product Code
    Regulation Number
    872.3930
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHOGEN, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    NanoGen is indicated for use in the following ways; by itself in bone regenerative techniques; mixed with other suitable bone filling agents to prevent particle migration in an osseous defect; and, to provide a resorbable barrier over other bone graft materials.
    Device Description
    NanoGen is a mixture of particles composed of densely packed grains of nanocrystalline calcium sulfate and medical grade calcium sulfate hemihydrate powder. The particles range from 400 - 850 microns in size. The particles of nanocrystalline calcium sulfate are purely synthetic and are manufactured from medical grade calcium sulfate hemihydrate through a proprietary process. Because of its unique structure, NanoGen undergoes controlled, slower degradation as compared to traditional calcium sulfate. NanoGen is designed to set-up in vivo and may be used either alone or mixed with DFDBA (demineralized freeze-dried bone allograft) or autogenous bone in bone in bone regenerative procedures. It is mixed with small amounts of normal saline to produce a putty-like paste and is then applied to the bone defects. Set NanoGen dissolves with time. The calcium present in NanoGen is believed to contribute to the mineralization of newly regenerated bone.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1