FDA Registration
Active
🇮🇹 Italy
Adler Ortho SpA
Reg #: 3036773273
·
FEI: 3036773273
·
Expires 2026
Products
8
Proprietary Names
8
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- Adler Ortho SpA
- Registration Number
- 3036773273
- FEI Number
- 3036773273
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Viale Trento 115/117
- City
- Mezzolombardo Trento
- Country
- IT
Owner / Operator
- Firm Name
- Adler Ortho S.p.A.
- Operator Number
- 10086224
- Address
- Via Dell'Innovazione 9
- City
- Cormano
- State
- Milano
- Postal Code
- 20032
- Country
- IT
- Correspondent
- Edgardo Cremascoli
US Agent
- Business Name
- Pivot MedTech, LLC
- Contact Name
- Albert Nanni
- Address
- 323 New Albany Rd
- City
- Moorestown
- State
- NJ
- ZIP
- 08057
- Country
- US
- [email protected]
- Phone
- 856 2961691
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2022-11-16 |
| Prosthesis, Upper Femoral | JDD | Class 2 | Orthopedic | No | 2024-12-11 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2023-01-26 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2025-01-29 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2025-01-29 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2025-01-29 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2025-06-25 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2023-04-26 |
Proprietary Names
CUSTOM MADE HIP PROSTHESIS, UNCEMENTED
CUSTOM MADE UPPER FEMORAL PROSTHESIS
CUSTOM MADE HIP PROSTHESIS, UNCEMENTED, HA COATED
Pantheon Proximal Femur Reconstruction (PFR) System
CUSTOM MADE HIP PROSTHESIS, CEMENTED
Custom-made, Knee, Constrained, Cemented, Metal/Polymer
CUSTOM MADE FEMORAL PROSTHESIS, POROUS & UNCEMENTED
CUSTOM MADE KNEE JOINT PROSTHESIS, UNCEMENTED
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)