FDA Registration
Active
🇺🇸 United States
SignatureTM Personalized Patient Care System
Reg #: 3005718816
·
FEI: 3005718816
·
Expires 2025
Products
7
Proprietary Names
3
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- Materialise USA, LLC.
- Registration Number
- 3005718816
- FEI Number
- 3005718816
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 44650 Helm Court
- City
- Plymouth
- State
- MI
- ZIP
- 48170
- Country
- US
Regulatory Submissions
- 510(k) Number
- K111863
Owner / Operator
- Firm Name
- MATERIALISE N.V.
- Operator Number
- 9029485
- Address
- Technologielaan 15, --
- City
- Leuven
- State
- BE-NOTA
- Postal Code
- 3001
- Country
- BE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2012-07-06 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2012-07-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2012-07-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2012-07-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2012-07-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2012-07-06 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2012-07-06 |
Proprietary Names
SignatureTM Personalized Patient Care System
SignatureTM Planner
SignatureTM Guide
Establishment Types
Manufacture Medical Device