Total clearances
13
2020-02-26 → 2026-06-03
Name variants in FDA filings: 3D Systems, Inc. / 3D Systems
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| 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 |
— |
— |
— |
1 |
2022-03-30 |
Filings
All 510(k) clearances (13)
| 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 |
— |
— |
| 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 |