LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K991964
    Device Name
    EIS THREADED SCREW FRACTURE FIXATION
    Manufacturer
    GROUPE LEPINE
    Date Cleared
    1999-12-20

    (193 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EIS THREADED SCREW FRACTURE FIXATION

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

    The Groupe Lepine EIS threaded compression screw system is intended to be used as a fixation screw of the first metatarsal after a corrective osteotomy, or for fixation of small bones after trauma fractures.

    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 fractures.

    Device Description

    EIS Threaded Compression Screw System

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the EIS Threaded Screws for Metatarsal Fixation, which describes the device's intended use and market clearance, but does not include any details about acceptance criteria, a study validating the device's performance, or the specific information you've requested regarding AI or clinical studies.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1