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.
FDA 510(k) Cleared Plate, Bone Devices (Product Code JEY)
About Product Code JEY - Regulatory Context
510(k) Submission Activity
292 total 510(k) submissions under product code JEY since 1984, with 292 receiving FDA clearance (average review time: 133 days).
Submission volume has declined in recent years - 6 submissions in the last 24 months compared to 8 in the prior period.
FDA Review Time
Recent submissions under JEY have taken an average of 160 days to reach a decision - up from 132 days historically. Manufacturers should account for longer review timelines in current project planning.
JEY devices are reviewed by the Dental panel. Browse all Dental devices →