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510(k) Data Aggregation

    K Number
    K191817
    Device Name
    ActivOrtho Continuous Compression Screw System
    Manufacturer
    ActivOrtho, Inc.
    Date Cleared
    2019-07-26

    (21 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    ActivOrtho, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Activ Ortho Continuous Compression Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of small bones and small bone fragments.
    Device Description
    The ActivOrtho Continuous Compression Screw System is a cannulated Nitinol bone screw having various sizes to accommodate a variety of applications. The screws are headed, cannulated, and partially threaded. The continuous compression screw incorporates a helical expansion section in the smooth shaft of the screw which elongates as the distal thread engages bone to produce a continuous compression force across the fracture site.
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