VSP System
FDA 510(k) K210347 · 3D Systems
510(k) numberK210347
Submission
- Device name
- VSP System
- Applicant
- 3D Systems
Littleton, CO, US - Received
- February 8, 2021
- Decision date
- April 26, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code DZJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261826 | VSP System (Titanium Palatal Splint)DZJ · Traditional | 3D Systems, Inc. | 06/03/2026SE |
| K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryDZJ · Traditional | Materialise NV | 02/21/2025SE |
| K242263 | TECHFIT DISRP® SystemDZJ · Traditional | Techfit Digital Surgery, Inc. | 12/11/2024SE |
| K231520 | tmCMF SolutionDZJ · Traditional | Techmah Cmf | 10/02/2023SE |
| K230276 | TECHFIT DISRP® SystemDZJ · Traditional | Techfit Digital Surgery | 06/23/2023SE |
| K223024 | MedCAD AccuPlan SystemDZJ · Traditional | Medcad | 03/07/2023SE |
| K220366 | EmbedMedDZJ · Traditional | 3D Lifeprints UK , Ltd. | 09/30/2022SE |
| K220648 | OMF ASP SystemDZJ · Traditional | Vha Dean | 08/11/2022SE |
| K212570 | OsteoPlan SystemDZJ · Traditional | Osteomed, LLC | 02/11/2022SE |
| K201353 | CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemDZJ · Traditional | Centermed, Inc. | 06/28/2021SE |
More from Centermed, Inc.
| 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 |
Questions and answers
When was VSP System cleared by the FDA?
VSP System (K210347) received a 510(k) decision of Substantially Equivalent on April 26, 2021, 77 days after the submission was received.
What is the product code of K210347?
The FDA product code is DZJ – Driver, Wire, And Bone Drill, Manual, a Class II (moderate risk) device regulated under 21 CFR 872.4120.