FDA Registration
Active
🇪🇸 Spain
OsteoSinter® EVANS and COTTON wedges and related accessories
Reg #: 3036718423
·
FEI: 3036718423
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AMES MEDICAL PROSTHETIC SOLUTIONS, S.A.U.
- Registration Number
- 3036718423
- FEI Number
- 3036718423
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Ctra. Laurea Miro, 388
- City
- St. Feliu del Llobregat Barcelona
- Country
- ES
Regulatory Submissions
- 510(k) Number
- K240461
Owner / Operator
- Firm Name
- AMES MEDICAL Prosthetic Solutions, S.A.U.
- Operator Number
- 10092888
- Address
- Ctra. Laurea Miro, 388
- City
- St. Feliu del Llobregat
- State
- Barcelona
- Postal Code
- 08980
- Country
- ES
- Correspondent
- Emili Tarrats
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bone Wedge | PLF | Class 2 | Orthopedic | No | 2025-03-03 |
Proprietary Names
OsteoSinter® EVANS and COTTON wedges and related accessories
Establishment Types
Manufacture Medical Device