FDA Registration
Active
🇪🇸 Spain
WasherCap Fixation System
Reg #: 3025608439
·
FEI: 3025608439
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- ABANZA TECNOMED, S.L.
- Registration Number
- 3025608439
- FEI Number
- 3025608439
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Calle Nueva 29
- City
- MUTILVA Navarra
- Country
- ES
Regulatory Submissions
- 510(k) Number
- K212197
Owner / Operator
- Firm Name
- ABANZA TECNOMED, S.L.
- Operator Number
- 10086833
- Address
- Calle Nueva 29
- City
- MUTILVA
- State
- Navarra
- Postal Code
- 31192
- Country
- ES
US Agent
- Business Name
- Dawa Medical LCC
- Contact Name
- Stephan Toupin
- Address
- 7320 NW 12th Street, Suite 103
- City
- Miami
- State
- FL
- ZIP
- 33126
- Country
- US
- [email protected]
- Phone
- 786 7311159
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2022-12-20 |
Proprietary Names
WasherCap Fixation System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility