FDA Registration
Active
🇺🇸 United States
VanDuzen, Inc. dba MedCAD
Reg #: 3009196021
·
FEI: 3009196021
·
Expires 2026
Products
8
Proprietary Names
10
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- VanDuzen, Inc. dba MedCAD
- Registration Number
- 3009196021
- FEI Number
- 3009196021
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 501 S 2nd Ave Ste A1000
- City
- Dallas
- State
- TX
- ZIP
- 75226
- Country
- US
Regulatory Submissions
- 510(k) Number
- K220357
Owner / Operator
- Firm Name
- MedCAD
- Operator Number
- 10037478
- Address
- 501 Second Ave., Suite A-1000
- City
- Dallas
- State
- TX
- Postal Code
- 75226
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Template | HWT | Class 1 | Orthopedic | No | 2011-07-18 |
| Plate, Cranioplasty, Preformed, Non-Alterable | GXN | Class 2 | Neurology | No | 2022-08-31 |
| Driver, Wire, And Bone Drill, Manual | DZJ | Class 2 | Dental | No | 2021-07-20 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2021-07-20 |
| Orthopaedic Surgical Planning And Instrument Guides | PBF | Class 2 | Orthopedic | No | 2025-03-14 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2021-08-30 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2026-01-28 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2018-12-31 |
Proprietary Names
AccuModel
AccuShape Titanium Patient-Specific Cranial Implant
AccuShape
AccuPlan System 3DTi
MedCAD® AccuStride System
AccuPlan System Orthopedics
AccuPlate
AccuPlate Patient-Specific Plate
AccuPlate 3DTi Patient-Specific Plating System
AccuPlan Guide
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device