Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025608439

FEI Number

3025608439

Entity Name

ABANZA TECNOMED, S.L.

City/State/Country

MUTILVA Navarra, ES

Establishment Address

Calle Nueva 29, MUTILVA Navarra 31192, ES

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ABANZA TECNOMED, S.L. (Owner Number: 10086833)

Owner / Operator Contact Address

Calle Nueva 29, MUTILVA, ES-NA 31192, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 Countersink tool WasherCap Inserter 9mm & 10mm Handle with A/O connection system Positioner Guide 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-02-27
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2026-01-12
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2023-02-15
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2023-02-15
HWL	Set, Hollow Mill	Orthopedic	Class 1	888.4540	2023-01-11
HWW	Countersink	Orthopedic	Class 1	888.4540	2023-02-15

Official Correspondent

No official correspondent registered.

US Agent Details

Stephan Toupin Business: Dawa Medical LCC Email: stoupin@dawamedical.com Phone: (786) 7311159

Related Public Records

Same Entity

ABANZA TECNOMED, S.L.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22
K984200	R. Thomas Grotz, M.D., Inc.	STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE	1999-01-21
K171060	Riverpoint Medical	OrthoButton AL	2017-06-02
K231867	Paragon 28, Inc.	Grappler Suture Anchor System	2023-08-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

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3011989923	DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI	Istanbul, TR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025608439. Last updated year: 2026. Please use registration number 3025608439 when referencing this establishment in official correspondence.