Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Leforte Neuro System Bone Plate | N12-ME-001-05 | Jeil Medical Corporation | GWO GXR HBW JEY | 08809265155553 |
| Leforte System Bone Plate | 20-LR-434 | Jeil Medical Corporation | JEY | 08806390805223 |
| Leforte System Bone Plate | 24-RL-020 | Jeil Medical Corporation | JEY KTW | 08809265154365 |
| Leforte Neuro System Bone Plate | N16-GP-010S | Jeil Medical Corporation | GWO GXR HBW JEY | 08809265151913 |
| Leforte System Bone Plate | 24-RS-021 | Jeil Medical Corporation | JEY KTW | 08809265154334 |
| Leforte System Bone Plate | 20-CV-106-R | Jeil Medical Corporation | JEY | 08809265153511 |
| Leforte System Bone Plate | 20-ST-324 | Jeil Medical Corporation | JEY | 08809265153290 |
| Leforte System Bone Plate | 20-CV-026 | Jeil Medical Corporation | JEY | 08809265153023 |
| Leforte System Bone Plate | 12-LL-004 | Jeil Medical Corporation | JEY KTW | 08809265150527 |
| Leforte Neuro System Bone Plate | N16-CV-006 | Jeil Medical Corporation | GWO GXR HBW JEY | 08809265155683 |
| Leforte System Bone Plate | 20-ST-006 | Jeil Medical Corporation | JEY KTW | 08809265152330 |
| Leforte System Bone Plate | 20-ZR-034 | Jeil Medical Corporation | JEY | 08806390805247 |
| Leforte System Bone Plate | 20-LR-224-W | Jeil Medical Corporation | JEY | 08809265153344 |
| Leforte Neuro System Bone Plate | N12-ST-005 | Jeil Medical Corporation | GWO GXR HBW JEY | 08809265155409 |
| Leforte System Bone Plate | 16-RCL-012 | Jeil Medical Corporation | JEY | 08809265153580 |
| Leforte System Bone Plate | 24-ST-006 | Jeil Medical Corporation | JEY KTW | 08809265154273 |
| Leforte System Bone Plate | 16-RCR-008 | Jeil Medical Corporation | JEY | 08809265153634 |
| Leforte System Bone Plate | 20-LL-224-W | Jeil Medical Corporation | JEY | 08809265153368 |
| Leforte System Bone Plate | 20-LL-404-F | Jeil Medical Corporation | JEY | 08809265152774 |
| Leforte System Bone Plate | 20-LL-204-R | Jeil Medical Corporation | JEY | 08809265152675 |
| Leforte System Bone Plate | 20-CH-002 | Jeil Medical Corporation | JEY | 08809265153177 |
| Leforte System Bone Plate | 12-CD-012 | Jeil Medical Corporation | JEY KTW | 08809265150305 |
| Leforte System Bone Plate | 20-LR-404-R | Jeil Medical Corporation | JEY | 08809265152767 |
| Leforte Neuro System Bone Plate | NS-3MD-100-06 | Jeil Medical Corporation | GWO GXR HBW JEY | 08809265155737 |
| Leforte Neuro System Bone Plate | N16-ST-102 | Jeil Medical Corporation | GWO GXR HBW JEY | 08809265155614 |