FDA Registration
Active
🇺🇸 United States
SMR Shoulder System
Reg #: 3020967480
·
FEI: 3020967480
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- ProMade PoC Center for Complex Orthopedic Solutions at HSS
- Registration Number
- 3020967480
- FEI Number
- 3020967480
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 510 East 73rd St. (1st floor)
- City
- Manhattan
- State
- NY
- ZIP
- 10021
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201905
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 | 2020-12-21 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2020-12-21 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2020-12-21 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2020-12-21 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2020-12-21 |
Proprietary Names
SMR Shoulder System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)