FDA.reportPublic FDA data

MEDARTIS AG

Matched from indexed company URL: Medartis Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30032367023003236702MEDARTIS AG1N2026-01-01HOCHBERGERSTRASSE 60E BASEL Basel-Stadt CH CH-4057
30095407493009540749Medartis Inc.1Y2026-01-011195 Polk Drive Warsaw IN US 46582
30052158243005215824MEDARTIS, INC.1Y2020-04-25224 Valley Creek Boulevard Suite 100 Exton PA US 19341

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3093712021617865P240020TOUCH® CMC 1 ProsthesisSFA2025-07-10
547231558350663K993862MODUS SAGITTAL SPLIT PLATEJEY1999-12-29
547231465779966K992682MODUS 2.5 MANDIBULAR RECONSTRUCTION SETJEY1999-11-24
547231950801564K992106MODUS SYSTEM SELF-DRILLING SCREWSHWC1999-09-17
547231096607092K260934TITAN Nail; APTUS K-Wire SystemHWC2026-04-17
547231860272886K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5HRS2026-03-16
3093711860272886K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5HRS2026-03-16
547231056386253K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonHRS2025-03-07
3093711056386253K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonHRS2025-03-07
547231354065185K240613APTUS Elbow Dorsal Olecranon PlatesHRS2024-06-20
3093711354065185K240613APTUS Elbow Dorsal Olecranon PlatesHRS2024-06-20
547231997780283K234062APTUS Hand Scaphoid PlatesHRS2024-03-21
3093711368569290K232324StealthFix Intraosseous Fixation SystemJDR2023-08-30
547231356334431K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionHWC2023-11-03
547231879027036K232144Sterile Products of the APTUS SystemHRS2023-08-18
547231615120149K232105APTUS Foot System 2.8-3.5HRS2024-04-19
547231656496776K230971APTUS® 3.5 TriLock Straight PlatesHRS2023-06-02
547231890044055K223853Medartis APTUS® Ulna PlatesHRS2023-03-30
3093711707440951K220181StealthFix Intraosseous Fixation SystemJDR2022-03-22
3093711401906119K212979CalcShift™ Displacement Calcaneal Osteotomy SystemHRS2022-05-20
547231458595976K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire SystemHWC2020-11-06
3093711458595976K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire SystemHWC2020-11-06
3093711979805023K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw RangeHRS2020-03-23
547231832202542K193639APTUS® Foot 2.8-3.5 SystemHRS2020-03-26
3093711832202542K193639APTUS® Foot 2.8-3.5 SystemHRS2020-03-26
547231688000254K193633APTUS® Ankle Trauma System 2.8/3.5HRS2020-03-26
3093711688000254K193633APTUS® Ankle Trauma System 2.8/3.5HRS2020-03-26
547231426760320K193554APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemHRS2020-02-16
3093711426760320K193554APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemHRS2020-02-16
547231596752490K192984APTUS Clavicle SystemHRS2020-01-24
3093711596752490K192984APTUS Clavicle SystemHRS2020-01-24
547231109629818K192297APTUS Wrist Arthrodesis PlatesHRS2019-11-08
3093711109629818K192297APTUS Wrist Arthrodesis PlatesHRS2019-11-08
547231624454465K191848APTUS Wrist Spanning Plates 2.5HRS2019-09-30
547231019149188K191636APTUS Foot SystemJDR2019-08-16
3093711019149188K191636APTUS Foot SystemJDR2019-08-16
547231221730796K181425APTUS® Proximal Humerus SystemHRS2018-08-05
3093711221730796K181425APTUS® Proximal Humerus SystemHRS2018-08-05
547231013714097K181009APTUS CMC-I Fusion Plate SystemHRS2018-08-24
3093711013714097K181009APTUS CMC-I Fusion Plate SystemHRS2018-08-24
3093711418771336K180348Field Orthopaedics Micro Screw SystemHWC2018-07-17
547231679043833K172170APTUS(R) Wrist 2.5 SystemHRS2017-09-08
3093711679043833K172170APTUS(R) Wrist 2.5 SystemHRS2017-09-08
3093711741901141K163440Stealth Staple SystemJDR2017-02-01
547231346804098K161861APTUS® Coronoid 2.0HRS2017-02-09
3093711346804098K161861APTUS® Coronoid 2.0HRS2017-02-09
3093711356584336K153622First Ray Internal Bone Staple SystemJDR2016-04-08
547231212797734K142906APTUS Wrist 2.5 SystemHRS2015-06-09
3093711212797734K142906APTUS Wrist 2.5 SystemHRS2015-06-09
547231815159858K142581APTUS Foot SystemHRS2015-04-09
3093711815159858K142581APTUS Foot SystemHRS2015-04-09
547231401084520K141232APTUS ULNA SHORTENING 2.5HRS2014-06-23
3093711401084520K141232APTUS ULNA SHORTENING 2.5HRS2014-06-23
547231331793015K133460APTUS CANNULATED COMPRESSION SCREWSHWC2013-12-18
3093711331793015K133460APTUS CANNULATED COMPRESSION SCREWSHWC2013-12-18
547231349144403K120108APTUS PROXIMAL HUMERUS SYSTEMHRS2012-04-27
3093711349144403K120108APTUS PROXIMAL HUMERUS SYSTEMHRS2012-04-27
547231362155664K112560APTUS(R) DISTAL HUMERUS SYSTEMHRS2011-12-15
3093711362155664K112560APTUS(R) DISTAL HUMERUS SYSTEMHRS2011-12-15
547231339916583K112169APTUS WRIST ARTHRODESIS PLATESHRS2012-01-06
3093711339916583K112169APTUS WRIST ARTHRODESIS PLATESHRS2012-01-06
547231543886548K110908APTUS FOOT 3.5 SYSTEMHRS2011-06-28
3093711543886548K110908APTUS FOOT 3.5 SYSTEMHRS2011-06-28
547231061568802K110658APTUS CANNULATED COMPRESSION SCREWSHWC2011-06-02
3093711061568802K110658APTUS CANNULATED COMPRESSION SCREWSHWC2011-06-02
547231047027992K103332APTUS ULNA PLATESHRS2011-01-24
3093711047027992K103332APTUS ULNA PLATESHRS2011-01-24
547231691934260K102537APTUS 1.5 TRILOCKHRS2010-12-10
3093711691934260K102537APTUS 1.5 TRILOCKHRS2010-12-10
547231542835718K092038APTUS K-WIRE SYSTEMHTY2009-09-23
3093711542835718K092038APTUS K-WIRE SYSTEMHTY2009-09-23
547231701869446K091479APTUS FOOT SYSTEMHRS2009-07-13
3093711701869446K091479APTUS FOOT SYSTEMHRS2009-07-13
547231885872706K090983APTUS 2.0/2.3 FOUR CORNER FUSION PLATEHRS2009-07-01
3093711885872706K090983APTUS 2.0/2.3 FOUR CORNER FUSION PLATEHRS2009-07-01
547231219861555K090053APTUS 2.0 RADIAL HEAD SYSTEMHRS2009-04-23
3093711219861555K090053APTUS 2.0 RADIAL HEAD SYSTEMHRS2009-04-23
547231312374119K071612MODUS TRILOCK 2.0/2.3/2.5JEY2007-09-11
547231083597711K052061MODUS IMF SCREWS 2.0DZE2005-10-21
547232029622556K051946MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEMMQN2005-08-22
547231568068573K051567APTUS TITANIUM OSTEOSYNTHESIS SYSTEMHRS2005-08-23
3093711568068573K051567APTUS TITANIUM OSTEOSYNTHESIS SYSTEMHRS2005-08-23
547231019063960K050934MODUS TITANIUM OSTEOSYNTHESIS SYSTEMJEY2005-05-05
3093711031951465
3093711086672818
3093711100362001
3093711117611488
3093711133894504
547231246715792
3093711246715792
3093711301898362
3093711302976132
3093711314003268
3093711321133318
3093711327422197
3093711329115803
3093711339417164
3093711356845916
3093711359481101
3093711376687087
3093711380842147
3093711510274281
3093711534057021
3093711558983000
3093711581343151
547231587128554
3093711587128554
3093711591492296
3093711618999269
3093711629270302
547231645328668
3093711645328668
3093711656878899
3093711661452742
3093711680025560
3093711692692241
3093711856009090
3093711860588227
3093711893310800
3093711919888528

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS582026-03-16
HWC102026-04-17
JDR62023-08-30
JEY42007-09-11
HTY22009-09-23
DZE12005-10-21
MQN12005-08-22

PMN#

45 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next