LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K990436
    Device Name
    ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM
    Manufacturer
    BIODYNAMIC TECHNOLOGIES, INC.
    Date Cleared
    1999-03-31

    (48 days)

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

    ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM

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

    The ULTiMAX™ brand Trochanteric Intramedullary Rod System is indicated for single use to stabilize intertrochanteric and subtrochanteric fractures of the proximal femur.

    Device Description

    ULTiMAX™ Trochanteric Intramedullary Rod System II

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for a medical device called the "ULTiMAX™ Trochanteric Intramedullary Rod System II". This letter confirms that the device has been found substantially equivalent to a predicate device and can be marketed.

    However, the letter does not contain any information about acceptance criteria or the study that proves the device meets specific performance criteria. It is a regulatory clearance document, not a detailed technical report or a clinical study summary.

    Therefore, I cannot provide the requested information based only on the provided input. The document's purpose is to grant market authorization based on substantial equivalence, not to detail the specific performance validation results.

    To answer your request, I would need a different type of document, such as:

    • A pre-market submission summary (e.g., a 510(k) summary or an IDE report)
    • A clinical study report
    • A peer-reviewed publication about the device's performance
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1