| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OYK | Ankle Arthroplasty Implantation System | Class II | Orthopedic | 6 | 2024-10-25 |
| DZJ | Driver, Wire, And Bone Drill, Manual | Class II | Dental | 3 | 2026-06-03 |
| PBF | Orthopaedic Surgical Planning And Instrument Guides | Class II | Orthopedic | 2 | 2025-12-05 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | Class II | Neurology | 1 | 2024-04-04 |
| IXI | Block, Beam-Shaping, Radiation Therapy | Class II | Radiology | 1 | 2022-03-30 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-06-03 | K261826 | VSP System (Titanium Palatal Splint) | DZJ | Class II | Dental |
| 2025-12-05 | K250711 | VSP Orthopedics System | PBF | Class II | Orthopedic |
| 2024-10-25 | K243174 | Cadence Ankle PSI System | OYK | Class II | Orthopedic |
| 2024-10-25 | K243173 | Salto Talaris Ankle PSI System | OYK | Class II | Orthopedic |
| 2024-08-30 | K241326 | Cadence Ankle PSI System | OYK | Class II | Orthopedic |
| 2024-08-30 | K241148 | Salto Talaris Ankle PSI System | OYK | Class II | Orthopedic |
| 2024-04-04 | K231834 | VSP PEEK Cranial Implant | GWO | Class II | Neurology |
| 2023-06-30 | K231585 | Vantage PSI System | OYK | Class II | Orthopedic |
| 2022-03-30 | K214093 | VSP Bolus | IXI | Class II | Radiology |
| 2021-11-10 | K211244 | VSP® Orthopedics System | PBF | Class II | Orthopedic |
| 2021-04-26 | K210347 | VSP System | DZJ | Class II | Dental |
| 2020-11-09 | K193432 | Vantage PSI System | OYK | Class II | Orthopedic |
| 2020-02-26 | K192192 | VSP System | DZJ | Class II | Dental |