Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003236702

FEI Number

3003236702

Entity Name

MEDARTIS AG

City/State/Country

BASEL Basel-Stadt, CH

Establishment Address

HOCHBERGERSTRASSE 60E, BASEL Basel-Stadt CH-4057, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MEDARTIS AG (Owner Number: 9033581)

Owner / Operator Contact Address

HOCHBERGERSTRASSE 60E, --, BASEL, CH-BS CH-4057, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K142581

PMA Number

N/A

All Registered Proprietary Names

APTUS Foot System 2.8-3.5 APTUS 1.5 TriLock APTUS CMC-I Fusion Plate System APTUS Shoulder Proximal Humerus System, PentaLock 3.5 APTUS Wrist 2.5 System APTUS Foot System APTUS Ulna Plates MODUS Sagittal Split Plate and Slider APTUS Titanium Fixation System MODUS TriLock 2/2.3/2.5 APTUS Ankle Trauma System 2.8/3.5 MODUS System Self-Drilling Screws APTUS Wrist Arthrodesis Plates CCS Line Extension APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System APTUS K-Wire System APTUS and MODUS Instruments PSN Drop Rod Adapter Lapidus Cut Guide Disposable Set Lapidus Cut Guide Patella Clamp Head PediLoc PediNail Lapiprep Lapidus Preparation System Cannulated Screws LCB StealthFix Intraosseous Fixation System Avenger Radial Head System BandLoc PediFrag PediFlex KeriFlex Instrumentation DFOS CalcShift Instrument System Response Spine PediFoot PNP APTUS 3.5 Straight Plates APTUS 2.5 TriLock Distal Ulna Plates APTUS Scaphoid Plates Olive K-Wire Guide Case Box Avenger Radial Head System Modul Rack Dispenser DFOS Container PediFlex Tray APTUS 2 Radial Head System TTS-Titanium Trauma Splint Titanium Arch Bar TTS Tooth Splint APTUS Elbow Dorsal Olecranon Plates APTUS Forearm APTUS and MODUS Drill Bits APTUS Cannulated Compression Screws APTUS Proximal Humerus System APTUS 2/2.3 Four Corner Fusion Plate MODUS 2.5 Mandibular Reconstruction System APTUS Proximal Humerus System Sterile Products of the APTUS System APTUS Clavicle APTUS Foot System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-09-09
PLF	Bone Wedge	Orthopedic	Class 2	888.3030	2024-09-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-09-09
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2010-12-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-08-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-03-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-03-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-06-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-06-10
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2010-12-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2010-12-10
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2011-02-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-02-14
JEY	Plate, Bone	Dental	Class 2	872.4760	2010-12-10
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2010-12-10
JEY	Plate, Bone	Dental	Class 2	872.4760	2010-12-10
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-04-16
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2020-04-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-04-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2006-01-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-01-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-01-09
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2024-01-09
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2020-11-11
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2020-11-11
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2020-11-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-11-11
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2010-12-10
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	1998-04-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-06-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-01-09
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-03-25
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-03-25
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-06-03
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-12-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2010-12-10
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2010-12-10
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2012-12-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-07-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-07-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-02-20
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2020-02-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-02-20
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2008-03-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-06-14
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-09-18
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2018-09-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-09-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2010-12-10
JEY	Plate, Bone	Dental	Class 2	872.4760	2010-12-10
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-06-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-05-23
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2024-05-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-05-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-02-20
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2020-02-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-02-20
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2020-02-20
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2020-02-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-04-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-04-13

Official Correspondent

No official correspondent registered.

US Agent Details

Elise Fox Business: Medartis Inc. Email: elise.fox@medartis.com Phone: (574) 3762062

Related Public Records

Same Entity

MEDARTIS AG

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009540749	Medartis Inc.	Warsaw, IN, US

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
K252254	Sinaptic Surgical	Osteotomy Wedge System	2025-10-17

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 3003236702. Last updated year: 2026. Please use registration number 3003236702 when referencing this establishment in official correspondence.