LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K974817
    Device Name
    DRG MF TITANIUN ALLOY BONE SCREW 1.0MM, 1.2MM, 1.3MM, 1.5MM, 1.7MM, 2.0MM, 2.4MM
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Date Cleared
    1998-03-13

    (80 days)

    Product Code
    DZL
    Regulation Number
    872.4880
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DRG MF Ti Alloy Bone screws are intended for craniofacial and mandibular trauma and reconstruction.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (DRG MF Titanium (Ti) Alloy Bone Screws). It does not contain any information about acceptance criteria, study details, performance data, or ground truth establishment. Therefore, I cannot fulfill your request to describe these elements based on the given input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1