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510(k) Data Aggregation

    K Number
    K212729
    Device Name
    Bone Cement-Normal Viscosity
    Manufacturer
    Biomecanica Industria e Comerciode Produtos Ortopedicos LTDA
    Date Cleared
    2022-05-31

    (277 days)

    Product Code
    LOD
    Regulation Number
    888.3027
    Why did this record match?
    Applicant Name (Manufacturer) :

    Biomecanica Industria e Comerciode Produtos Ortopedicos LTDA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bone Cement - Normal Viscosity is indicated for fixation of prostheses to live bone in musculoskeletal orthopedic surgical interventions in cases of rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe secondary destruction of the joints after trauma or other conditions and in the review of previous arthroplasty procedures.
    Device Description
    The Bone Cement - Normal Viscosity is a self-curing, radiopaque, polymethyl methacrylatebased cements used for securing a metal or polymeric prothesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties but rely instead on close mechanical interlock between the irregular bone surface and the prosthesis.
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