FDA Registration
Active
🇺🇸 United States
MEDICAL MODELING - A 3D SYSTEMS COMPANY
Reg #: 1724955
·
FEI: 3003142829
·
Expires 2026
Products
23
Proprietary Names
28
Establishment Types
2
Classifications
23
Registration Details
- Registration Name
- MEDICAL MODELING - A 3D SYSTEMS COMPANY
- Registration Number
- 1724955
- FEI Number
- 3003142829
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5381 SOUTH ALKIRE CIRCLE
- City
- Littleton
- State
- CO
- ZIP
- 80127
- Country
- US
Regulatory Submissions
- 510(k) Number
- K214093
Owner / Operator
- Firm Name
- 3D Systems, Inc.
- Operator Number
- 9052197
- Address
- 5381 South Alkire Circle
- City
- Littleton
- State
- CO
- Postal Code
- 80127
- Country
- US
- Correspondent
- Archana Gopalan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Block, Beam-Shaping, Radiation Therapy | IXI | Class 2 | Radiology | No | 2022-06-29 |
| Orthopaedic Surgical Planning And Instrument Guides | PBF | Class 2 | Orthopedic | No | 2023-02-16 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2023-01-25 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-04-16 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2025-04-23 |
| Ankle Arthroplasty Implantation System | OYK | Class 2 | Orthopedic | No | 2025-04-23 |
| Driver, Wire, And Bone Drill, Manual | DZJ | Class 2 | Dental | No | 2023-02-16 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2017-08-17 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2017-08-17 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2018-05-16 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2018-05-16 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2018-05-16 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2018-05-16 |
| Cranial Surgical Planning And Instrument Guides | PPT | Class 2 | Neurology | No | 2016-10-31 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2020-05-21 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2022-11-17 |
| Template | HWT | Class 1 | Orthopedic | No | 2002-07-19 |
| Prosthesis, Ankle, Uncemented, Non-Constrained | NTG | Class 3 | Unknown | No | 2022-12-21 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2017-01-13 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2013-10-31 |
| Knee Arthroplasty Implantation System | OOG | Class 2 | Orthopedic | No | 2013-10-31 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing | NJL | Class 3 | Unknown | No | 2016-10-31 |
| Plate, Cranioplasty, Preformed, Alterable | GWO | Class 2 | Neurology | No | 2024-09-03 |
Proprietary Names
VSP Bolus
Klarity Prints Bolus
CCSP Bolus
CCSP Orthopedics
VSP Orthopedics
VSP Orthopaedics
D2P
3D Systems Surgical Mask
Salto Talaris Ankle PSI System
VSP Trauma
VSP System
VSP Orthognathics
VSP Distraction
VSP Reconstruction
Jaw in a Day
VSP Cranial System
Cadence Ankle PSI System
3D Printed Nasal Swab
CardioView Anatomical Model
AccuView Anatomical Model
AccuDental Anatomical Model
OsteoView Anatomical Model
ClearView Anatomical Model
ArthroView Anatomical Model
VSP PEEK Cranial Implant
Vantage PSI
Vantage 3D+ PSI
Vantage 3D PSI
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)