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510(k) Data Aggregation

    K Number
    K991962
    Device Name
    EIS DYNAMIC MEMORY STAPLES SYSTEM
    Manufacturer
    GROUPE LEPINE
    Date Cleared
    2000-01-10

    (214 days)

    Product Code
    JDR
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EIS DYNAMIC MEMORY STAPLES SYSTEM

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

    The Groupe Lepine EIS dynamic memory staples system was designed and is intended to be used for the fixation of fractures by compressing two bones together after a osteotomy. The staples are intended for bone fixation after corrective osteotomy of the big toe, interphangeal fusion, fractures of the scaphoid or small trauma injuries.

    The indications for use of the screw system are as follows: to secure the two sections of bone after an osteotomy caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or arthritis secondary to a variety of diseases or anomalies or trauma fracture.

    Device Description

    EIS Dynamic Memory Staples System

    AI/ML Overview

    This is a 510(k) clearance letter for the EIS Dynamic Memory Staples System, a medical device. The letter states that the device is substantially equivalent to legally marketed predicate devices, and therefore, can be marketed.
    However, this document does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment relevant to an AI/ML device. It only provides regulatory clearance for a physical medical device (staples system). Therefore, I cannot extract the requested information.

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