| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| JEY | Plate, Bone | Class II | Dental | 1 | 2025-11-07 |
| HBW | — | — | — | 1 | 2025-07-11 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | 1 | 2021-01-13 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-11-07 | K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System | JEY | Class II | Dental |
| 2025-07-11 | K251472 | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System | HBW | — | — |
| 2021-01-13 | K203105 | Inion CompressOn Screw | HWC | Class II | Orthopedic |