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    K Number
    K230394
    Device Name
    EUROSCREW NG; EUROSCREW TCP NG
    Manufacturer
    Teknimed
    Date Cleared
    2023-05-12

    (87 days)

    Product Code
    MAI,DAT
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K122228
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K122228

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    EUROSCREW® NG and EUROSCREW® NG TCP screws are indicated in knee anterior cruciate ligament reconstruction in ligamentoplasty procedures.

    Device Description

    Teknimed's EUROSCREW® NG and EUROSCREW® TCP NG are bioabsorbable interference screws used in ligament surgery specifically designed for fixation of both bone-tendon-bone and soft tissue grafts. The screws are suitable and designed for ligamentoplasty surgical procedures specifically for knee anterior cruciate ligament reconstructions. Both are implantable screw devices in long term contact with bone and tissue grafts. Teknimed's EUROSCREW® NG and EUROSCREW® TCP NG are implant devices that are utilized in a surgical setting with a qualified healthcare professional (i.e., surgeons).

    AI/ML Overview

    This is not an AI/ML device, therefore, the requested information is not applicable.

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