FDA Product Code JEY: Plate, Bone

FDA product code JEY covers bone plates used in dental and maxillofacial surgery.

These titanium or resorbable plates are used to stabilize osteotomies and fractures of the mandible, maxilla, and midface. They are fixed with bone screws and provide rigid or semi-rigid fixation during healing of the bony segments.

JEY devices are Class II medical devices, regulated under 21 CFR 872.4760 and reviewed by the FDA Dental panel.

Leading manufacturers include Stryker Leibinger GmbH & Co KG, KLS-Martin L.P. and Techmah Cmf.