MEDARTIS AG

Registration Details

Registration Name: MEDARTIS AG
Registration Number: 3003236702
FEI Number: 3003236702
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: HOCHBERGERSTRASSE 60E
City: BASEL Basel-Stadt
Country: CH

Regulatory Submissions

510(k) Number: K232105

Owner / Operator

Firm Name: MEDARTIS AG
Operator Number: 9033581
Address: HOCHBERGERSTRASSE 60E, --
City: BASEL
State: Basel-Stadt
Postal Code: CH-4057
Country: CH

US Agent

Business Name: Medartis Inc.
Contact Name: Elise Fox
Address: 1195 Polk Drive
City: Warsaw
State: IN
ZIP: 46582
Country: US
Email: [email protected]
Phone: 574 3762062

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Plate, Fixation, Bone	HRS	Class 2	Orthopedic	No	2024-09-09
Bone Wedge	PLF	Class 2	Orthopedic	No	2024-09-09
Screw, Fixation, Bone	HWC	Class 2	Orthopedic	No	2024-09-09
Plate, Bone	JEY	Class 2	Dental	No	2010-12-10
Washer, Bolt Nut	HTN	Class 2	Orthopedic	No	2020-04-16
Pin, Fixation, Smooth	HTY	Class 2	Orthopedic	No	2024-01-09
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	Class 2	General Hospital	No	2020-11-11
Orthopedic Manual Surgical Instrument	LXH	Class 1	Orthopedic	No	1998-04-15
Tray, Surgical, Instrument	FSM	Class 1	General, Plastic Surgery	No	2024-03-25
Guide, Needle, Surgical	GDF	Class 1	General, Plastic Surgery	No	2014-06-03
Bracket, Metal, Orthodontic	EJF	Class 1	Dental	No	2012-12-10
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	KTT	Class 2	Orthopedic	No	2020-02-20
Bit, Drill	HTW	Class 1	Orthopedic	No	2008-03-14
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	Class 2	Orthopedic	No	2020-02-20
Staple, Fixation, Bone	JDR	Class 2	Orthopedic	No	2019-08-20
Implant, Endosseous, Root-Form	DZE	Class 2	Dental	No	2006-01-23
External Mandibular Fixator And/Or Distractor	MQN	Class 2	Dental	No	2006-01-23
Template	HWT	Class 1	Orthopedic	No	2024-05-23

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 Modul Rack Dispenser Container 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 Sterile Products of the APTUS System APTUS Clavicle APTUS Ulna Shortening 2.5 APTUS Cannulated Compression Screws 5/7 Staple All-in-One MODUS IMF Screws 2 APTUS Wrist Arthrodesis APTUS Distal Humerus System APTUS Hand System MODUS Modular Distraction Osteogenesis System Template TITAN Nail APTUS Foot 3.5 System APTUS Coronoid 2 MODUS Titanium Ostheosynthesis System APTUS Foot 2.8-3.5 System

Establishment Types

Manufacture Medical Device