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510(k) Data Aggregation

    K Number
    K990920
    Device Name
    DRG TITANIUM BONE PLATE
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Date Cleared
    1999-06-10

    (84 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DRG TITANIUM BONE PLATE

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

    DRG Ti Bone Plates are intended for craniofacial and mandibular trauma and reconstruction.

    Device Description

    DRG Titanium Bone Plate

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "DRG Titanium Bone Plate." It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria for a new AI/software medical device.

    The clearance letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory obligations. It mentions the "indications for use" for the bone plate, but this is a statement of what the device is intended for, not performance metrics.

    Therefore, I cannot provide the requested information based on the provided text. The document is about a hardware medical device (a bone plate) and its regulatory clearance, not an AI or software-based medical device performance study.

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