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510(k) Data Aggregation

    K Number
    K013755
    Device Name
    CONCERT RADIOPAQUE BONE CEMENT
    Manufacturer
    IMMEDICA, INC.
    Date Cleared
    2002-02-08

    (87 days)

    Product Code
    LOD
    Regulation Number
    888.3027
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CONCERT RADIOPAQUE BONE CEMENT

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

    Fixation of prostheses to living bone in orthopedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, severe joint destruction secondary to trauma or other conditions and revision of previous arthroplasty.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a medical device clearance. It does not contain information about acceptance criteria, study details, or performance data for a device. The document is primarily about the regulatory approval of "Concert Radiopaque Bone Cement" and its intended use.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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