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510(k) Data Aggregation

    K Number
    K210285
    Device Name
    Adaptable Ortho Innovations Intramedullary Nail System
    Manufacturer
    Adaptable Ortho Innovations, LLC
    Date Cleared
    2021-03-18

    (44 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    Adaptable Ortho Innovations, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Adaptable Ortho Innovations Intramedullary Nail System is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non-unions.
    Device Description
    The Adaptable Ortho Innovations Intramedullary Nail System consists of an adjustable length intramedullary nail, locking screws, and end caps. All implants are manufactured from Ti-6Al-4V ELI per ASTM F136. The nail system is available in a range of lengths and diameters to accommodate varying patient anatomy.
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