JEY — Plate, Bone Class II
FDA Device Classification
Classification Details
- Product Code
- JEY
- Device Class
- Class II
- Regulation Number
- 872.4760
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K253373 | southern medical (pty) | Southern Craniomaxillofacial (CMF) System | December 19, 2025 |
| K251441 | inion | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsor | November 7, 2025 |
| K241314 | kls-martin l.p | KLS Martin Oral-Max Implants MR Conditional (bundled) | August 16, 2024 |
| K240651 | stryker leibinger gmbh and co kg | MRI Universal | July 12, 2024 |
| K233874 | techmah cmf | tmCMF Solution | July 11, 2024 |
| K232889 | meticuly co | METICULY Patient-specific titanium maxillofacial mesh implant | April 30, 2024 |
| K232350 | stryker craniomaxillofacial | Stryker Facial iD System | January 13, 2024 |
| K230398 | medcad | MedCAD® AccuPlate® 3DTi Patient-Specific Plating System | September 26, 2023 |
| K230733 | stryker leibinger gmbh and co kg | Stryker Resorbable Fixation System | August 5, 2023 |
| K222650 | stryker craniomaxillofacial (cmf) | Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate | December 9, 2022 |
| K220360 | microware precision co | Tandry CMF Plate System | November 10, 2022 |
| K221855 | stryker leibinger gmbh and co kg | Universal CMF System | November 9, 2022 |
| K210731 | kls-martin l.p | KLS Martin Individual Patient Solutions | July 18, 2022 |
| K213777 | stryker leibinger micro implants | Stryker Resorbable Fixation System | February 4, 2022 |
| K202969 | biomet microfixation | Biomet Microfixation OmniMax MMF System | August 5, 2021 |
| K202918 | sites medical | OsteoSync Ti Dental Mesh | July 14, 2021 |
| K203282 | industrias medicas sampedro | TECHFIT Patient-Specific Maxillofacial System | May 19, 2021 |
| K193280 | medcad | MedCAD® AccuPlate® Patient-Specific Plate | February 12, 2021 |
| K201944 | synthes (usa) products | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) | September 10, 2020 |
| K182759 | montjade engineering co | BoniPlus Dental G-Mesh System | July 29, 2020 |