FDA Registration
Active
🇪🇸 Spain
ABANZA TECNOMED, S.L.
Reg #: 3025608439
·
FEI: 3025608439
·
Expires 2026
Products
10
Proprietary Names
35
Establishment Types
3
Classifications
10
Registration Details
- Registration Name
- ABANZA TECNOMED, S.L.
- Registration Number
- 3025608439
- FEI Number
- 3025608439
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Calle Nueva 29
- City
- MUTILVA Navarra
- Country
- ES
Regulatory Submissions
- 510(k) Number
- K250238
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 | 2025-02-27 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2023-02-15 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2023-02-15 |
| Set, Hollow Mill | HWL | Class 1 | Orthopedic | No | 2023-01-11 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2023-02-15 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2023-02-15 |
| Positioner, Socket | KIL | Class 1 | Orthopedic | No | 2023-01-12 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2025-03-04 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2023-02-15 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2023-02-15 |
Proprietary Names
WasherCap Fixation System
QuadLock Fixation System
Sterilization tray 7mm-10mm and 8mm-11mm
Positioner Guide
Inserter Coupling Screw 7mm-11mm
Countersink tool
WasherCap Inserter 7mm-11mm
WasherCap Countersink Positioner 10mm
WasherCap Countersink 10mm
WasherCap Countersink 9mm
WasherCap Inserter 9mm & 10mm
Handle with A/O connection system
WasherCap Countersink 8mm
WasherCap Screwdriver
Awl 7mm & 8mm
WasherCap Countersink Positioner 7mm
WasherCap Countersink Positioner 8mm
WasherCap Inserter 11mm
Inserter Coupling Screw 7mm & 8mm
WasherCap Surgical Instrument Set
Awl 9mm & 10mm & 11mm
Sterilization Tray
Kirschner Wire
WasherCap Countersink 11mm
WasherCap Countersink Positioner 11mm
WasherCap Inserter 7mm & 8mm
Inserter Coupling Screw 9mm & 10mm
WasherCap Countersink Positioner 9mm
Inserter Coupling Screw 11mm
WasherCap Countersink 7mm
WasherCap Countersink 7 mm-11mm
Handle with AO connection system
WasherCap Countersink Positioner 7mm-11mm
WasherCap Mini Fixation System
Awl 7mm-11mm
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device