FDA Registration
Active
🇨🇭 Switzerland
Medacta Total Hip System
Reg #: 3005180920
·
FEI: 3005180920
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MEDACTA INTERNATIONAL SA
- Registration Number
- 3005180920
- FEI Number
- 3005180920
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Strada Regina
- City
- Castel San Pietro Ticino
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K072857
Owner / Operator
- Firm Name
- Medacta International SA
- Operator Number
- 10024526
- Address
- Strada Regina
- City
- Castel San Pietro
- State
- Ticino
- Postal Code
- 6874
- Country
- CH
- Correspondent
- Stefano Baj
US Agent
- Business Name
- Medacta USA
- Contact Name
- Christopher Lussier
- Address
- 6386 Global Drive, Suite 101
- City
- Memphis
- State
- TN
- ZIP
- 38141
- Country
- US
- [email protected]
- Phone
- 901 2033470
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2008-02-11 |
Proprietary Names
Medacta Total Hip System
Quadra S Stems
Quadra R Stems
Quadra H Stems, Quadra C Stems
Establishment Types
Manufacture Medical Device