LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K982488
    Device Name
    BICON BONE SCREW SYSTEM
    Manufacturer
    BICON, INC.
    Date Cleared
    1999-01-26

    (193 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BICON BONE SCREW SYSTEM

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

    The Bicon Bone Screws are indicated for those cases where a clinician desires to have a temporary prosthesis attached to bone.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for the "Bicon Bone Screw System" and an "Indications for Use" statement. This type of document from the FDA does not contain information about acceptance criteria for a device's performance, nor does it detail studies proving that the device meets such criteria.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has met the regulatory requirements for market clearance, primarily based on demonstrating similarity to existing devices. It does not include performance metrics or study details in the way typically found in a clinical trial report or scientific publication.

    Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1