LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K091382
    Device Name
    KRYPTONITE BONE CEMENT
    Manufacturer
    DOCTORS RESEARCH GROUP, INC.
    Date Cleared
    2009-11-16

    (189 days)

    Product Code
    GXP
    Regulation Number
    882.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOCTORS RESEARCH GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Kryptonite Bone Cement™ is a resinous material for repairing cranial defects.
    Device Description
    Kryptonite Bone Cement™ is a resinous material to be used as a cranial bone void filler. Kryptonite Bone Cement™ is a self-setting bone cement that is formed by combining and mixing three components, resulting in a mild exothermic polymeric reaction (less than body temperature) that polymerizes into a malleable putty and progresses to a hard cement-like complex. The three components of Kryptonite Bone Cement™ are a liquid pre-polymer isocyanate mixture, a liquid polyester polyol, and a powdered calcium carbonate.
    Ask a Question

    Page 1 of 1