JEY — Plate, Bone Class II
FDA product code JEY covers "Plate, Bone", a Class II medical device regulated under 21 CFR 872.4760. Submissions are reviewed by the Dental panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K252246 | jeil medical corporation | Leforte MMF System | April 2, 2026 |
| 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 |