Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010158639

FEI Number

3010158639

Entity Name

MAWATEC AG

City/State/Country

Selzach Solothurn, CH

Establishment Address

Selzacherstrasse 32, Selzach Solothurn 2545, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Mawatec AG (Owner Number: 10043561)

Owner / Operator Contact Address

Selzacherstrasse 32, Selzach, CH-SO 2545, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MONOAXIAL T-15 TORX SCREWDRIVER DJD II BODY NUMELOCK II HUMERUS PLATEDISTAL LAT. 5 HOLE RIGHT NUMELOCK II RADIUS PLATE DISTAL 4 HOLE LEFT NUMELOCK II RADIUS PLATE DISTAL 4 HOLE RIGHT NUMELOCK II HUMERUS PLATEPROXIMAL 4 HOLE RIGHT NUMELOCK II HUMERUS PLATEDISTAL LAT. 3 HOLE RIGHT NUMELOCK II HUMERUS PLATEDISTAL LAT. 2 HOLE LEFT NUMELOCK II HUMERUS PLATEPROXIMAL 4 HOLE LEFT NUMELOCK II HUMERUS PLATEDISTAL MED. 3 HOLE NUMELOCK II HUMERUS PLATEPROXIMAL 6 HOLE RIGHT NUMELOCK II HUMERUS PLATEDISTAL MED. 1 HOLE NUMELOCK II HUMERUS PLATEDISTAL LAT. 5 HOLE LEFT NUMELOCK II HUMERUS PLATEPROXIMAL 8 HOLE LEFT NUMELOCK II HUMERUS PLATEPROXIMAL 10 HOLE RIGHT NUMELOCK II HUMERUS PLATEDISTAL LAT. 2 HOLE RIGHT NUMELOCK II HUMERUS PLATEPROXIMAL 6 HOLE LEFT NUMELOCK II HUMERUS PLATEPROXIMAL 10 HOLE LEFT NUMELOCK II RADIUS PLATE DISTAL 3 HOLE RIGHT NUMELOCK II HUMERUS PLATEPROXIMAL 8 HOLE RIGHT NUMELOCK II RADIUS PLATE DISTAL 3 HOLE LEFT NUMELOCK II HUMERUS PLATEDISTAL LAT. 3 HOLE LEFT NUMELOCK II SYSTEM OMEGA3 TSP PLATE VARIAX CLAVICLE - TRIAL - SUP LATERAL / 3 HOLE / LEFT VARIAX CLAVICLE - TRIAL - SUP DECREASED / 7 HOLE / RIGHT VARIAX CLAVICLE - TRIAL- ANT LATERAL / 8 HOLE VARIAX CLAVICLE - TRIAL- ANT MIDSHAFT / 8 HOLE VARIAX CLAVICLE - TRIAL - SUP LATERAL / 3 HOLE / RIGHT VARIAX CLAVICLE - TRIAL - SUP LATERAL / 4 HOLE / LEFT VARIAX CLAVICLE - TRIAL - SUP DECREASED / 6 HOLE / LEFT VARIAX CLAVICLE - TRIAL - SUP INCREASED / 8 HOLE / RIGHT VARIAX CLAVICLE - TRIAL - SUP LATERAL / 7 HOLE / RIGHT VARIAX CLAVICLE - TRIAL - SUP DECREASED / 10 HOLE / LEFT VARIAX CLAVICLE - TRIAL - SUP DECREASED / 8 HOLE / LEFT VARIAX CLAVICLE - TRIAL- ANT LATERAL / 6 HOLE VARIAX CLAVICLE - TRIAL - SUP INCREASED / 8 HOLE / LEFT VARIAX CLAVICLE - TRIAL- ANT MIDSHAFT / 7 HOLE VARIAX CLAVICLE - TRIAL- ANT MIDSHAFT / 6 HOLE VARIAX CLAVICLE - TRIAL - SUP DECREASED / 8 HOLE / RIGHT VARIAX CLAVICLE - TRIAL - SUP DECREASED / 6 HOLE / RIGHT VARIAX CLAVICLE - TRIAL- ANT LATERAL / 7 HOLE VARIAX CLAVICLE - TRIAL - SUP LATERAL / 4 HOLE / RIGHT VARIAX CLAVICLE - TRIAL - SUP LATERAL / 7 HOLE / LEFT VARIAX CLAVICLE - TRIAL - SUP INCREASED / 10 HOLE / RIGHT VARIAX CLAVICLE - TRIAL - SUP DECREASED / 7 HOLE / LEFT VARIAX CLAVICLE - TRIAL- ANT MIDSHAFT / 10 HOLE VARIAX CLAVICLE - TRIAL - SUP INCREASED / 10 HOLE / LEFT VARIAX CLAVICLE - TRIAL - SUP LATERAL / 5 HOLE / LEFT VARIAX CLAVICLE - TRIAL - SUP DECREASED / 10 HOLE / RIGHT VARIAX CLAVICLE - TRIAL - SUP LATERAL / 5 HOLE / RIGHT Aiming Device 3.5mm 4 SCREW HOLDING SLEEVE DRILL GUIDE BLOCK COMPACT 4 HOLE OVERDRILL GUIDE LOCKING SCREW HOLDING SLEEVE NUMELOCK II HUMERUS PLATE DISTAL MED. 5 HOLE K WIRE SLEEVE FOR 5 SYSTEM DRILL SLEEVE L=68MM DRILL GUIDE BLOCK HII 10 HOLE DEPTH GAUGE FOR LOCKING SCREWS LOCKING INSERT INTRODUCER 5 SCREW HOLDING SLEEVE DRILL GUIDE FOR CIRCULAR LOCKING HOLES PERCUTANEOUS DRILL SLEEVE DRILL SLEEVE HANDLE VARIAX DRILL GUIDE 2MM COMPRESSION AND POLYAXIAL SCREWDRIVER BLADE, AO, T10 MONOAXIAL T-20 TORX SCREWDRIVER K WIRE SLEEVE L=60MM DRILL GUIDE FOR OBLONG COMPRESSION HOLES DRILL SLEEVE SHORT 3.2mm COMP. MONOAXIAL T-15 TORX SCREWDRIVER VARIAX DRILL GUIDE 2.6MM COMPRESSION AND POLYAXIAL NEUTRAL PERCUTANEOUS DRILL SLEEVE - DIA 2.5 DRILL SLEEVE SHORT 2.5mm NEUT. DRILL SLEEVE SHORT 2.5mm BUTTR DRILL SLEEVE SHORT 2.5mm COMP. DRILL SLEEVE FOR 4 SYSTEM DRILL GUIDE BLOCK HII 5 HOLE K WIRE SLEEVE FOR 4 SYSTEM T-20 SCREWDRIVER BIT DRILL SLEEVE SHORT 3.2mm BUTTR DRILL SLEEVE FOR 5 SYSTEM T-15 SCREWDRIVER BIT OMEGA KEYLESS PLATE 145 OMEGA KEYLESS PLATE 135 OMEGA KEYLESS PLATE 130 OMEGA KEYLESS PLATE 140 OMEGA KEYLESS PLATE 150 HOOK PLATE 9 HOLE / 20MM / LEFT HOOK PLATE 7 HOLE / 12MM / RIGHT HOOK PLATE 5 HOLE / 16MM / RIGHT HOOK PLATE 9 HOLE / 16MM / LEFT HOOK PLATE 7 HOLE / 20MM / RIGHT PLATE TRIAL FOR HOOK PLATE DEPTH - 20MM LEFT HOOK PLATE 6 HOLE / 16MM / LEFT HOOK PLATE 6 HOLE / 20MM / LEFT HOOK PLATE 5 HOLE / 12MM / RIGHT HOOK PLATE 5 HOLE / 12MM / LEFT HOOK PLATE 5 HOLE / 16MM / LEFT PLATE TRIAL FOR HOOK PLATE DEPTH - 12MM RIGHT PLATE TRIAL FOR HOOK PLATE DEPTH - 20MM RIGHT PLATE TRIAL FOR HOOK PLATE DEPTH - 16MM RIGHT HOOK PLATE 9 HOLE / 12MM / RIGHT HOOK PLATE 5 HOLE / 20MM / RIGHT HOOK PLATE 9 HOLE / 16MM / RIGHT HOOK PLATE 6 HOLE / 12MM / RIGHT HOOK PLATE 6 HOLE / 20MM / RIGHT HOOK PLATE 7 HOLE / 16MM / RIGHT HOOK PLATE 7 HOLE / 12MM / LEFT HOOK PLATE 6 HOLE / 16MM / RIGHT HOOK PLATE 7 HOLE / 16MM / LEFT PLATE TRIAL FOR HOOK PLATE -RULER HOOK PLATE 5 HOLE / 20MM / LEFT HOOK PLATE 9 HOLE / 12MM / LEFT PLATE TRIAL FOR HOOK PLATE DEPTH - 16MM LEFT HOOK PLATE 7 HOLE / 20MM / LEFT PLATE TRIAL FOR HOOK PLATE DEPTH - 12MM LEFT HOOK PLATE 9 HOLE / 20MM / RIGHT HOOK PLATE 6 HOLE / 12MM / LEFT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-01-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-01-16
LXT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	Orthopedic	Class 2	888.3030	2013-02-27
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2013-02-27
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2013-02-27
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2013-02-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-02-10
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-02-10
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2023-08-14
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-02-27
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2013-02-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-01-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-01-16

Official Correspondent

Dominik Lehmann

US Agent Details

Yong Sun Business: EMERGO GLOBAL REPRESENTATION LLC Email: USAgent@UL.com Phone: (512) 3279997

Related Public Records

Same Entity

Mawatec AG

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
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08

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-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010158639. Last updated year: 2026. Please use registration number 3010158639 when referencing this establishment in official correspondence.