JEY
- Product code
- JEY
- Device name
- Plate, Bone
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.4760
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 11
- Summaries archived here
- 11 (direct download)
- 510(k) clearances (all years, FDA)
- 294 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (11)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260137 | 2026-08-17 | KLS-Martin L.P. | KLS Martin IPS Oral-Max Implants - MR Conditional; I… | |
| K253206 | 2026-07-25 | Meticuly Co., Ltd. | METICULY Patient-specific CMF solution | |
| K252246 | 2026-04-02 | Jeil Medical Corporation | Leforte MMF System | |
| K253373 | 2025-12-19 | Southern Medical (Pty) , Ltd. | Southern Craniomaxillofacial (CMF) System | |
| K251441 | 2025-11-07 | Inion OY | Inion CPS 1.5 Baby Bioabsorbable Fixation System; In… | |
| K241314 | 2024-08-16 | KLS-Martin L.P. | KLS Martin Oral-Max Implants MR Conditional (bundled… | |
| K240651 | 2024-07-12 | Stryker Leibinger GmbH & Co KG | MRI Universal | |
| K233874 | 2024-07-11 | Techmah Cmf | tmCMF Solution | |
| K232889 | 2024-04-30 | Meticuly Co., Ltd. | METICULY Patient-specific titanium maxillofacial mes… | |
| K232350 | 2024-01-13 | Stryker Craniomaxillofacial | Stryker Facial iD System | |
| K230398 | 2023-09-26 | Medcad | MedCAD® AccuPlate® 3DTi Patient-Specific Plating Sys… |
Official FDA classification page: JEY
Classification and pathway per current FDA publications. Data from openFDA (CC0).