Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003661942

FEI Number

3003661942

Entity Name

Wymed Precision Mechanics

City/State/Country

Embrach Zurich, CH

Establishment Address

Hard Strasse 20, Embrach Zurich 8424, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Wymed Precision Mechanics (Owner Number: 10043076)

Owner / Operator Contact Address

Obstgartenweg 1, Freienstein, CH-ZH 8427, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

77015121-500 Medial Tibia Plate 12H LT 7622-1050-500 LEOS MTP Plate SM 5° Lt 770513060-500 1.5mm/2mm Straight Plate Flat 6H 770709101-500 Posterior Fibula Plate 10H LT 770504050-500 1.5mm/2mm Y Tine Plate, 5H 7622-1000-500 LEOS MTP Plate, SM. 0°, Lt 7622-1003-500 MTP FUSION PLATE, MD, 0 , RIGHT 770715162-500 Medial Tibia Plate 16H RT 7622-1253-500 LEOS MTP Revision Plate, MD, 5°, Rt 770709141-500 Tibia Fibula Plate 14H LT 7622-1052-500 LEOS MTP Fusion Plate, SM, 5°, Rt 770715102-500 Medial Tibia Plate 10H RT 770708062-500 Anatomic Lateral Fibula Plat 6H 770715122-500 Medial Tibia Plate 12H RT 7622-1001-500 MTP FUSION PLATE, MD, 0 , LEFT 770711150-500 1/3 Tubular Plate 15H 770722200-500 2.7mm High Strength Plate, 20H 770714122-500 Anterolateral Tibia Plate 12H RT W TWA-CP Capitate Planar DRLL-SSC-27080, Drill, 2.7mm x 80mm K-Wire, 1.4mm/.9mm x 171mm, Double Trocar Stepped DRLL-SSC-25040, Drill, Solid Side Cutting 2.5mm x 40mm HNDL-UQC-RTC, Handle, Universal Quick Connect, RTC KWIR-ST-07152, K-Wire, Single Trocar, 0.7mm x 152mm WG-ST-09152 Wire Guide Tapered .9mm x 152mm INST-CRG-14W, Crego Elevator, Full Curve, 14mm Wi DRLL-SSC-20080, Drill, 2mm x 80mm TWA-CR-3 Carpal Component Reamer Size 3 KWIR-DTS-20152 K-Wire Single Diamond Tip Threaded, 2mm x 152mm DRLL-PS-18 Drill 1.8mm Cannilated Phalanx Stabiliz KWIR-OLV-12064, K-Wire Threaded OS, 1.2mmx64mm TWA-CR-4 Carpal Component Reamer Size 4 TWA-CS-1 Capitate Shaper Size 1 HNDL-UQC-FXD, Handle, Universal Quick Connect, Fix KWCC-SD-12089, K-Wire Single Diamond 1.2mmx89mm HNDL-SQC-FXD, Handle, Small Quick Connect, Fixed TWA-RDR-5 Radial Dish Reamer Size 5 DRLL-SSC-27040, Drill, 2.7mm x 40mm TWA-RDR-1 Radial Dish Reamer Size 1 INST-UNJ Universal Joint, AO Adapter DRLL-SSC-35050, Drill, 3.5mm x 50mm TQA-16, AO to AO Torque Adaptor, 1.6 NM ALN-RHA-TQH, Torque Handle, Radial Head KWIR-STD-15127, K-Wire, 1.6mm x 127mm DRLL-SSC-35070, Drill, 3.5mm x 70mm DRLL-SSC-27050, Drill, 2.7mm x 50mm INST-HR-SM, Heiss Retractor, Small, blunt TWA-CS-5 Capitate Shaper Size 5 KWCC-DD-09089, K-Wire Double Diamond 0.9mmx89mm KWIR-TOD-16127, K-Wire 1.6mm Threaded Olive TWA-CR-1 Carpal Component Reamer Size 1 KWCC-DD-12089, K-Wire Double Diamond 1.2mmx89mm TWA-CR-5 Carpal Component Reamer Size 5 TQA-20, AO to AO Torque Adaptor, 2NM DRLL-20124R Drill, 2mm x 124mm, Reusable DRLL-SSC-20040, Drill, Solid Side Cutting 2.5mm x 40mm INST-WC-SM, Wire Cutterm, Small, Angled DRLL-SSC-23040, Drill, 2.3mm x 40mm DRLL - 27018 Drill, 2.7mm x 18mm DRLL-SSC-25050, Drill, 2.5mm x 50mm TWA-RDR-3 Radial Dish Reamer Size 3 KWCC-SD-09089, K-Wire Single Diamond 0.9mmx89mm DRLL-CS-2030 Drill, Cross Screw, 2mm x 30mm DRLL-POST-38 Drill Post 3.8mm TWA-RDR-2 Radial Dish Reamer Size 2 DRLL-20018 Drill, 2mm x 18mm DRLL-SSC-25080, Drill, 2.5mm x 80mm TWA-CR-2 Carpal Component Reamer Size 2 42-891 Saw Blade, Icotec Systems

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-02-19
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2023-04-10
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-04-01
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2026-04-01

Official Correspondent

Pascal Duerst

US Agent Details

Mark Weisbrod Email: mark.weisbrod@wymed.ch Phone: (804) 3161892

Related Public Records

Same Entity

Wymed Precision Mechanics

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
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25
K202803	Newclip Technics	Activmotion S DTO	2021-12-16
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003661942. Last updated year: 2026. Please use registration number 3003661942 when referencing this establishment in official correspondence.