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510(k) Data Aggregation

    K Number
    K120978
    Device Name
    OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR
    Manufacturer
    MERETE MEDICAL GMBH
    Date Cleared
    2012-05-02

    (30 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K101939
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intramedullary knee arthrodesis

    Indications include:

    1. Irretrievably failed total knee arthroplasty
    2. Limb salvage
    3. Oncology surgery
    4. Any other condition where there is little soft tissue or bony tissue available for support and arthrodesis is the treatment of choice

    The intramedullary rods can be fixed with interlocking screws without or with bone cement.

    Device Description

    OsteoBridge® IKA Intramedullary Knee Arthrodesis Rod Fixation System

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification decision letter from the FDA for a medical device (OsteoBridge® IKA Intramedullary Knee Arthrodesis Rod Fixation System). It is a regulatory document confirming clearance for marketing and outlines general compliance requirements.

    This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications related to an AI/ML-driven medical device.

    Therefore, I cannot fulfill your request for the specific information outlined in points 1-9.

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