JEY · Plate, Bone
Dental · 21 CFR 872.4760 · Class 2
Overview
| Product Code | JEY |
|---|---|
| Device Name | Plate, Bone |
| Regulation | 21 CFR 872.4760 |
| Device Class | Class 2 |
| Review Panel | Dental |
| Implant | Yes |
Identification
A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 292)
Showing 20 most recent of 292 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252246 | Leforte MMF System | Jeil Medical Corporation | Apr 2, 2026 | SESE |
| K253373 | Southern Craniomaxillofacial (CMF) System | Southern Medical (Pty) , Ltd. | Dec 19, 2025 | SESE |
| K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System | Inion OY | Nov 7, 2025 | SESE |
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) | KLS-Martin L.P. | Aug 16, 2024 | SESE |
| K240651 | MRI Universal | Stryker Leibinger GmbH & Co KG | Jul 12, 2024 | SESE |
| K233874 | tmCMF Solution | Techmah Cmf | Jul 11, 2024 | SESE |
| K232889 | METICULY Patient-specific titanium maxillofacial mesh implant | Meticuly Co., Ltd. | Apr 30, 2024 | SESE |
| K232350 | Stryker Facial iD System | Stryker Craniomaxillofacial | Jan 13, 2024 | SESE |
| K230398 | MedCAD® AccuPlate® 3DTi Patient-Specific Plating System | Medcad | Sep 26, 2023 | SESE |
| K230733 | Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co KG | Aug 5, 2023 | SESE |
| K222650 | Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate | Stryker Craniomaxillofacial (Cmf) | Dec 9, 2022 | SESE |
| K220360 | Tandry CMF Plate System | Microware Precision Co., Ltd. | Nov 10, 2022 | SESE |
| K221855 | Universal CMF System | Stryker Leibinger GmbH & Co KG | Nov 9, 2022 | SESE |
| K210731 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | Jul 18, 2022 | SESE |
| K213777 | Stryker Resorbable Fixation System | Stryker Leibinger Micro Implants | Feb 4, 2022 | SESE |
| K202969 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | Aug 5, 2021 | SESE |
| K202918 | OsteoSync Ti Dental Mesh | Sites Medical, LLC | Jul 14, 2021 | SESE |
| K203282 | TECHFIT Patient-Specific Maxillofacial System | Industrias Medicas Sampedro S.A.S | May 19, 2021 | SESE |
| K193280 | MedCAD® AccuPlate® Patient-Specific Plate | Medcad | Feb 12, 2021 | SESE |
| K201944 | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) | Synthes (USA) Products, LLC | Sep 10, 2020 | SESE |
Top Applicants
- Synthes (Usa) — 38 clearances
- Bioplate, Inc. — 16 clearances
- KLS-Martin L.P. — 15 clearances
- Walter Lorenz Surgical, Inc. — 15 clearances
- Stryker — 13 clearances
