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510(k) Data Aggregation

    K Number
    K981230
    Device Name
    ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
    Manufacturer
    BIODYNAMIC TECHNOLOGIES, INC.
    Date Cleared
    1998-06-01

    (59 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 DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM

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

    The ULTiMAX™ brand Distal Femoral Intramedullary Rod System is indicated for single use to stabilize distal femoral fractures, including supracondylar fractures, severely comminuted supracondylar fractures with difficult intra-articular extension, fractures that require stabilization of the femoral condylar segment, distal fractures in osteoporotic bone, pathologic fractures, pseudoarthrosis, malunions and failed distal femoral osteosynthesis.

    Device Description

    ULTiMAX™ Distal Femoral Intramedullary Rod System

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot extract information about the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for the ULTiMAX™ Distal Femoral Intramedullary Rod System, which primarily discusses the substantial equivalence of the device to a predicate device and its indications for use. It does not contain details about specific performance acceptance criteria or performance study results.

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