Product code JEY
Current FDA Classification
- Device name
- Plate, Bone
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.4760
- Review panel
- DE
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252246 | Leforte MMF System | Jeil Medical Corporation | 2026-04-02 |
| K253373 | Southern Craniomaxillofacial (CMF) System | Southern Medical (Pty) , Ltd. | 2025-12-19 |
| K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System | Inion OY | 2025-11-07 |
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) | KLS-Martin L.P. | 2024-08-16 |
| K240651 | MRI Universal | Stryker Leibinger GmbH & Co KG | 2024-07-12 |
| K233874 | tmCMF Solution | Techmah Cmf | 2024-07-11 |
| K232889 | METICULY Patient-specific titanium maxillofacial mesh implant | Meticuly Co., Ltd. | 2024-04-30 |
| K232350 | Stryker Facial iD System | Stryker Craniomaxillofacial | 2024-01-13 |
| K230398 | MedCAD® AccuPlate® 3DTi Patient-Specific Plating System | Medcad | 2023-09-26 |
| K230733 | Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co KG | 2023-08-05 |
| K222650 | Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate | Stryker Craniomaxillofacial (Cmf) | 2022-12-09 |
| K220360 | Tandry CMF Plate System | Microware Precision Co., Ltd. | 2022-11-10 |
| K221855 | Universal CMF System | Stryker Leibinger GmbH & Co KG | 2022-11-09 |
| K210731 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | 2022-07-18 |
| K213777 | Stryker Resorbable Fixation System | Stryker Leibinger Micro Implants | 2022-02-04 |
| K202969 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | 2021-08-05 |
| K202918 | OsteoSync Ti Dental Mesh | Sites Medical, LLC | 2021-07-14 |
| K203282 | TECHFIT Patient-Specific Maxillofacial System | Industrias Medicas Sampedro S.A.S | 2021-05-19 |
| K193280 | MedCAD® AccuPlate® Patient-Specific Plate | Medcad | 2021-02-12 |
| K201944 | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) | Synthes (USA) Products, LLC | 2020-09-10 |
| K182759 | BoniPlus Dental G-Mesh System | Montjade Engineering Co., Ltd. | 2020-07-29 |
| K192747 | Yxoss CBR® | Reoss GmbH | 2020-06-17 |
| K191997 | FAICO CMF System | Faico Medical, LLC | 2020-04-22 |
| K193143 | Stryker Facial iD Plating System | Stryker | 2020-03-26 |
| K193136 | Stryker Customized Mandible Recon Plate Kit | Stryker | 2020-03-26 |
| K192655 | Depuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | 2019-12-30 |
| K182758 | MCI - CMF System | Mci Medical Concept Innovation, Inc. | 2019-12-05 |
| K191028 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | 2019-11-22 |
| K190696 | Stryker Surgeon iD Mandible Recon Plate | Stryker | 2019-06-28 |
| K182609 | Delphos Implants Rigid Fixation System | Delphos Implants - Ind.Com. Importacao E Exportacao DE | 2019-03-29 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00888118149848 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118153128 | LEVEL ONE NEURO, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149985 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149978 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149961 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149954 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149947 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149930 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149923 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149916 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149909 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149893 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149886 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149879 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149855 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149671 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149831 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149824 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149817 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149800 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149794 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149787 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149770 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149763 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149756 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149749 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149732 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149725 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149718 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |
| 00888118149701 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-03-23 |