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Clinical Trial Summary

This study will address medical devices manufactured by Biomet Microfixation (d.b.a. Zimmer Biomet) designed for fixation and stabilization of the facial and mandibular skeleton.


Clinical Trial Description

The subject devices are: - plates, screws, and primary instruments from the Biomet Microfixation Facial Plating System, including plates to be specifically used in orthognathic procedures - plates, screws and primary instruments for the Mandibular Plating System, including and a device intended to temporarily restore the functionality of the temporomandibular joint for patients whose natural condyle has to be resected, subsequent to a tumor ablation ("Add-On Condyle") Additionally, a third device intended for the replacement of bony voids in the facial skeleton will be evaluated in this trial (HTR-PEKK- facial application). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04931056
Study type Observational
Source Zimmer Biomet
Contact
Status Completed
Phase
Start date October 1, 2021
Completion date November 30, 2023

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