FDA Registration
Active
🇺🇸 United States
MedCAD
Reg #: 3021635140
·
FEI: 3021635140
·
Expires 2026
Products
6
Proprietary Names
8
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- MedCAD
- Registration Number
- 3021635140
- FEI Number
- 3021635140
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3401 Technology Dr, Unit 3
- City
- Plano
- State
- TX
- ZIP
- 75074
- Country
- US
Regulatory Submissions
- 510(k) Number
- K192282
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 |
|---|---|---|---|---|---|
| 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 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2023-09-27 |
| Orthopaedic Surgical Planning And Instrument Guides | PBF | Class 2 | Orthopedic | No | 2023-09-21 |
| Plate, Cranioplasty, Preformed, Non-Alterable | GXN | Class 2 | Neurology | No | 2011-07-18 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2026-01-28 |
Proprietary Names
AccuPlate 3DTi Patient-Specific Plating System
AccuPlan System 3DTi
AccuPlan System Orthopedics
AccuShape
MedCAD® AccuStride System
AccuPlate
AccuPlate Patient-Specific Plate
AccuShape Titanium Patient-Specific Cranial Implant
Establishment Types
Manufacture Medical Device