LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K183666
    Device Name
    EBA One Nailing System
    Manufacturer
    CITIEFFE S.r.l.
    Date Cleared
    2019-11-14

    (322 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EBA One Nailing System

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

    EBA One Nailing System standard trochanteric nail is indicated for the treatment of stable intertrochanteric fractures, pertrochanteric fractures, non-unions, mal-unions.

    EBA One Nailing System long trochanteric nail is indicated for the treatment of pertrochanteric fractures with extension of the fracture line to the diaphysis,pertrochanteric fractures associated with diaphyseal fractures (bifocal fractures), pathological fractures, non-unions, mal-unions.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the EBA One Nailing System. It is not a study report for an AI/ML medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, or comparative effectiveness studies for an AI/ML device.

    The information you are asking for typically comes from a clinical validation study or performance testing report, which would be part of a 510(k) submission for an AI/ML device, but isn't explicitly detailed in the FDA clearance letter itself unless specifically summarized.

    This letter solely confirms that the EBA One Nailing System (an intramedullary fixation rod, a physical implant, not an AI/ML software) has been deemed substantially equivalent to legally marketed predicate devices.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1