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510(k) Data Aggregation
K Number
K033092Device Name
THE GNATHOMETER
Manufacturer
Date Cleared
2004-04-21
(205 days)
Product Code
Regulation Number
872.4760Why 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.
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