Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K033092
    Device Name
    THE GNATHOMETER
    Manufacturer
    Date Cleared
    2004-04-21

    (205 days)

    Product Code
    Regulation Number
    872.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHO GNATHICS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Gnathometer is a jaw tracking apparatus designed to provide maxillofacial surgeons with an accurate means to measure distances relative to a defined three-dimensional reference system of x-y-z coordinates on the patient's head. The Gnathometer is intended for use only by maxillofacial surgeons performing corrective surgical procedures on patients with dentofacial deformittes. The Gnathometer's use during surgery is intended to assist in confirming the location and relocation of the patient's teeth and jaws with prescribed, pre-surgically designed relocations that remedy the patients dentofacial deformities. The Gnathometer is intended only to make contact with a patient at four (4) predetermined points on the skull via tightening screws and a halo device, and not to be attached to the jaws.
    Device Description
    The Gnathometer is a jaw tracking apparatus.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1