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510(k) Data Aggregation

    K Number
    K092670
    Device Name
    BIODRIVE MICRO SCREW SYSTEM
    Manufacturer
    EBI,LLC D/B/A BIOMET TRAUMA
    Date Cleared
    2009-11-19

    (80 days)

    Product Code
    HRS, HWC, PAG
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    EBI,LLC D/B/A BIOMET TRAUMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Biomet BioDrive Screw System is indicated for alignment and stabilization of small bone fractures. Specifically: - Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand for . treatment of fractures, non-unions, or mal-unions - Ligament reconstruction - Osteochondritis dissecans - Arthrodesis of the foot, ankle, wrist, elbow and hand - Small bone osteotomies, including first metatarsal head osteotomy, metatarsal . osteotomies, phalangeal osteotomies, and carpal/metacarpal osteotomies These procedures may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.
    Device Description
    The Biomet BioDrive Micro Screw System consists of screws, a micro nail plate and ancillary instruments intended for surgery to aid in alignment and stabilization of fractures of small bones such as those in the foot, elbow, ankle, and hand.
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