3D Systems, Inc.
Rock Hill, SC, US
3D SYSTEMS, INC. appears in FDA device records in Rock Hill, SC. FDA records list 17 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 17 510(k) clearances for 3D Systems, Inc. between 2016 and 2026. The busiest year on record is 2024, with 5. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2017 | 1 |
| 2019 | 2 |
| 2020 | 2 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 5 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261826 | VSP System (Titanium Palatal Splint) | DZJ | Substantially Equivalent | |
| K250711 | VSP Orthopedics System | PBF | Substantially Equivalent | |
| K243174 | Cadence Ankle PSI System | OYK | Substantially Equivalent | |
| K243173 | Salto Talaris Ankle PSI System | OYK | Substantially Equivalent | |
| K241326 | Cadence Ankle PSI System | OYK | Substantially Equivalent | |
| K241148 | Salto Talaris Ankle PSI System | OYK | Substantially Equivalent | |
| K231834 | VSP PEEK Cranial Implant | GWO | Substantially Equivalent | |
| K231585 | Vantage PSI System | OYK | Substantially Equivalent | |
| K214093 | VSP Bolus | IXI | Substantially Equivalent | |
| K211244 | VSP® Orthopedics System | PBF | Substantially Equivalent | |
| K210347 | VSP System | DZJ | Substantially Equivalent | |
| K193432 | Vantage PSI System | OYK | Substantially Equivalent | |
| K192192 | VSP System | DZJ | Substantially Equivalent | |
| K183489 | D2P | LLZ | Substantially Equivalent | |
| K190044 | VSP Orthopedics System | PBF | Substantially Equivalent | |
| K161841 | D2P | LLZ | Substantially Equivalent | |
| K151285 | VSP Cranial System | PPT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1000263603 | 1000263603 | 3D SYSTEMS, INC. | 321 Three D Systems Circle, Rock Hill, SC 29730 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OYKAnkle Arthroplasty Implantation System
- IXIBlock, Beam-Shaping, Radiation Therapy
- PPTCranial Surgical Planning And Instrument Guides
- DZJDriver, Wire, And Bone Drill, Manual
- PBFOrthopaedic Surgical Planning And Instrument Guides
- GWOPlate, Cranioplasty, Preformed, Alterable
- LLZSystem, Image Processing, Radiological
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain