FDA Registration
Active
🇮🇹 Italy
PRIMA Humeral System
Reg #: 3008395353
·
FEI: 3008395353
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Limacorporate S.p.A.
- Registration Number
- 3008395353
- FEI Number
- 3008395353
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Zona Industriale Contrada Fegotto
- City
- Calatafimi Segesta (TP) Sicilia
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K212800
Owner / Operator
- Firm Name
- Limacorporate S.p.A.
- Operator Number
- 10032506
- Address
- Via Nazionale 52
- City
- Villanova di San Daniele
- State
- Udine
- Postal Code
- 33038
- Country
- IT
- Correspondent
- Roberto Gabetta
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2022-03-01 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2022-03-01 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2022-03-01 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2022-03-01 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2022-03-01 |
Proprietary Names
PRIMA Humeral System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)