510(k) K252246
- Device
- Leforte MMF System
- Applicant
- Jeil Medical Corporation
- 510(k) number
- K252246
- Product code
- JEY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-02
- Date received
- 2025-07-18
- Regulation
- 872.4760
- Classification name
- Plate, Bone
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Jinwoo Kim
- Address
- 702703704705706707804805807812815-Ho, 55 Digital-Ro 34-Gil, Guro-Gu Seoul KR 08378 08378
FDA Registration Numbers
- 3003587896
- 1057946
- 1650372
- 3004464325
- 3009158523
- 1824199
- 2032098
- 3015212339
- 1066741
- 3034676720
- 3013111692
- 9610612
- 3010326886
- 2027754
- 2029005
- 3015882686
- 3017521423
- 3010162973
- 3014483751
- 3009551666
- 2024024
- 3011423165
- 2916714
- 3007923096
- 8010177
- 3005554774
- 8010099
- 1060818
- 3011302692
- 2530154
- 9710629
- 3002862271
- 1649518
- 9681465
- 3005515228
- 3025141
- 1030489
- 3011824442
- 3021635140
- 1057425
- 3002807310
- 2032542
- 3009417901
- 3010287729
- 8031010
- 3000270450
- 3006001176
- 3014937101
- 3015780293
- 1828288
- 3008791302
- 1420032
- 3008812560
- 3009196021
- 1226425
- 1825034
- 3017734069
- 9681851
- 3015531529
- 9610905
- 3009555440
- 3005497913
- 2431866
- 3009555447
- 3011724582
- 1054986
- 8030965
- 1647149
- 3015876273
- 3006017180
- 3007738812
- 3003322138
- 3003898943
- 1032347
- 2029275
- 3031886796
- 2029447
- 3004049923
- 3004431266
- 3008868758
- 9612468
- 3030089802
- 3005718816
- 1000606483
- 3015869121
- 9614438
- 3015440604
- 3011530718
- 3003236702
- 3015399803
- 3027157194
- 3015869493
- 3009383407
- 3011196443
- 3010155648
- 3003394081
- 8010468
- 9610921
- 3003108161
- 3014128887
- 8043792
- 3010362364
- 3010363503
- 3018094310
- 3003998208
- 3004187715
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code JEY
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |