FDA Registration
Active
🇮🇹 Italy
VALTECNE SPA
Reg #: 3027484613
·
FEI: 3027484613
·
Expires 2026
Products
16
Proprietary Names
10
Establishment Types
2
Classifications
16
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Registration Details
- Registration Name
- VALTECNE SPA
- Registration Number
- 3027484613
- FEI Number
- 3027484613
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Via al Campo Sportivo 277
- City
- Berbenno di Valtellina Sondrio
- Country
- IT
Owner / Operator
- Firm Name
- Valtecne SpA
- Operator Number
- 10089402
- Address
- Via al Campo Sportivo 277
- City
- Berbenno di Valtellina
- State
- Sondrio
- Postal Code
- 23010
- Country
- IT
- Correspondent
- Fabio Esposito
US Agent
- Business Name
- Mellingen Consulting
- Contact Name
- Sherri Mellingen
- Address
- 7205 Dahlgren Rd
- City
- Chaska
- State
- MN
- ZIP
- 55318
- Country
- US
- [email protected]
- Phone
- 952 9136383
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2024-03-15 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2024-03-15 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2024-03-15 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2024-03-15 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2024-03-15 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2024-03-15 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2024-03-15 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2024-03-15 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2024-03-15 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2024-03-15 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2024-03-15 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2024-03-15 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2024-03-15 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2024-03-15 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2024-03-15 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2024-03-15 |
Proprietary Names
SMR Shoulder System
SMR Hybrid Glenoid System
SMR 40MM GLENOSPHERE
Orthopedic manual surgical instrument
Delta Dual Mobility System
PHYSICA KR KNEE SYSTEM
MINIMA S SYSTEM
AWL
MASTER SL FEMORAL STEM
PRIMA Humeral System and SMR Glenosphere diam. 42
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Sterilize Medical Device for Another Party (Contract Sterilizer)