3D Systems, Inc.
Medical device manufacturer in Littleton, CO.
17510(k) clearances
0PMA approvals
0recalls
Device types
- OYK Ankle Arthroplasty Implantation System 6
- PBF Orthopaedic Surgical Planning And… 3
- DZJ Driver, Wire, And Bone Drill, Manual 3
- LLZ System, Image Processing, Radiological 2
- PPT Cranial Surgical Planning And Instrument… 1
- IXI Block, Beam-Shaping, Radiation Therapy 1
- GWO Plate, Cranioplasty, Preformed, Alterable 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K261826 | VSP System (Titanium Palatal Splint)DZJ · Traditional | 06/03/2026SE |
| K250711 | VSP Orthopedics SystemPBF · Traditional | 12/05/2025SE |
| K243174 | Cadence Ankle PSI SystemOYK · Special | 10/25/2024SE |
| K243173 | Salto Talaris Ankle PSI SystemOYK · Special | 10/25/2024SE |
| K241326 | Cadence Ankle PSI SystemOYK · Traditional | 08/30/2024SE |
| K241148 | Salto Talaris Ankle PSI SystemOYK · Traditional | 08/30/2024SE |
| K231834 | VSP PEEK Cranial ImplantGWO · Traditional | 04/04/2024SE |
| K231585 | Vantage PSI SystemOYK · Special | 06/30/2023SE |
| K214093 | VSP BolusIXI · Traditional | 03/30/2022SE |
| K211244 | VSP® Orthopedics SystemPBF · Traditional | 11/10/2021SE |
| K210347 | VSP SystemDZJ · Traditional | 04/26/2021SE |
| K193432 | Vantage PSI SystemOYK · Traditional | 11/09/2020SE |
| K192192 | VSP SystemDZJ · Traditional | 02/26/2020SE |
| K183489 | D2PLLZ · Traditional | 08/29/2019SE |
| K190044 | VSP Orthopedics SystemPBF · Traditional | 08/21/2019SE |
| K161841 | D2PLLZ · Traditional | 01/09/2017SE |
| K151285 | VSP Cranial SystemPPT · Traditional | 09/23/2016SE |