Data / Medical devices / Spain / Abanza Tecnomed, S.L.
Abanza Tecnomed, S.L.: FDA-registered device maker in MUTILVA Navarra, Spain, 4 510(k) clearances
Abanza Tecnomed, S.L. is registered with the FDA (registration 3025608439) in MUTILVA Navarra, Spain. It lists 10 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 6, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025608439
- Address
- Calle Nueva 29, MUTILVA Navarra, Spain, 31192
- Owner or operator
- ABANZA TECNOMED, S.L. (10086833)
- Roles
- Complaint file establishment, Exporter to the US, Specification developer
- First device listed
- December 20, 2022
- Registered through
- 2026
- Brand names listed
- Awl 7mm & 8mm, Awl 7mm-11mm, Awl 9mm & 10mm & 11mm, Countersink tool, Handle with A/O connection system, Handle with AO connection system, Inserter Coupling Screw 11mm, Inserter Coupling Screw 7mm & 8mm and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Awl | HWJ | 1 | Specification developer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Countersink | HWW | 1 | Specification developer | accessdata.fda.gov |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Specification developer | accessdata.fda.gov |
| Positioner, Socket | KIL | 1 | Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Specification developer | accessdata.fda.gov |
| Set, Hollow Mill | HWL | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 6, 2026 | K253618 | QuadLock Fixation System | MBI | Substantially Equivalent | Abanza Tecnomed S.L | accessdata.fda.gov |
| February 25, 2025 | K250238 | WasherCap Fixation System | MBI | Substantially Equivalent | Abanza Tecnomed S.L | accessdata.fda.gov |
| January 30, 2025 | K243712 | WasherCap Mini Fixation System (Model 45) | MBI | Substantially Equivalent | Abanza Tecnomed S.L | accessdata.fda.gov |
| September 22, 2022 | K212197 | WasherCap Fixation System | MBI | Substantially Equivalent | Abanza Tecnomed S.L | accessdata.fda.gov |
Compare with other makers
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
- All makers of Awl
- All makers of Bit, Drill
- All makers of Screwdriver
- All makers of Handle, Scalpel
- All makers of Positioner, Socket
Updated January 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.