FDA Registration
Active
🇺🇸 United States
ProMade PoC Center for Complex Orthopedic Solutions at HSS
Reg #: 3020967480
·
FEI: 3020967480
·
Expires 2026
Products
11
Proprietary Names
11
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- ProMade PoC Center for Complex Orthopedic Solutions at HSS
- Registration Number
- 3020967480
- FEI Number
- 3020967480
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 510 East 73rd St. (1st floor)
- City
- Manhattan
- State
- NY
- ZIP
- 10021
- Country
- US
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, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2022-03-01 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | 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 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2019-11-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2019-11-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2019-11-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2019-11-06 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2019-11-26 |
| Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | PKC | Class 2 | Orthopedic | No | 2023-03-24 |
Proprietary Names
PRIMA Humeral System
Delta Multihole TT Pro Acetabular System
Delta TT Jumbo Cups
SMR TT Augmented Glenoid System
PRIMA TT Glenoid
SMR Shoulder System
Delta Liners
Delta TT Cups
SMR Stemless Anatomic
Delta TT Pro
Delta Dual Mobility System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)