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510(k) Data Aggregation

    K Number
    K053492
    Device Name
    BIODUCT
    Manufacturer
    BIODUCT, LLC
    Date Cleared
    2007-04-12

    (483 days)

    Product Code
    MAI
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIODUCT, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BioDuct's Meniscal Fixation Device is intended for fixation of longitudinal vertical meniscus (bucket handle) lesions located in the vascularized (red-white) zone of the meniscus when used with suture.
    Device Description
    BioDuct's Meniscal Fixation Device is an arthroscopically implanted, cannulated, bioabsorbable (PLA) device used with suture, and is available in sizes ranging from 5 to 14 mm long. The Meniscal Fixation Device is designed to be placed between the synovium and a lesion located in less well vascularized (red-white) areas of the meniscus.
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