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 Biomet Microfixation.
List of Plate, Bone devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Plate, Bone devices (product code JEY). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Dental FDA review panel. Browse all Dental devices →