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MEDARTIS AG

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30032367023003236702MEDARTIS AG1N2026-01-01HOCHBERGERSTRASSE 60E BASEL Basel-Stadt CH CH-4057

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
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
547231056386253K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonHRS2025-03-07
547231354065185K240613APTUS Elbow Dorsal Olecranon PlatesHRS2024-06-20
547231997780283K234062APTUS Hand Scaphoid PlatesHRS2024-03-21
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
547231458595976K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire SystemHWC2020-11-06
547231832202542K193639APTUS® Foot 2.8-3.5 SystemHRS2020-03-26
547231688000254K193633APTUS® Ankle Trauma System 2.8/3.5HRS2020-03-26
547231426760320K193554APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemHRS2020-02-16
547231596752490K192984APTUS Clavicle SystemHRS2020-01-24
547231109629818K192297APTUS Wrist Arthrodesis PlatesHRS2019-11-08
547231624454465K191848APTUS Wrist Spanning Plates 2.5HRS2019-09-30
547231019149188K191636APTUS Foot SystemJDR2019-08-16
547231221730796K181425APTUS® Proximal Humerus SystemHRS2018-08-05
547231013714097K181009APTUS CMC-I Fusion Plate SystemHRS2018-08-24
547231679043833K172170APTUS(R) Wrist 2.5 SystemHRS2017-09-08
547231346804098K161861APTUS® Coronoid 2.0HRS2017-02-09
547231212797734K142906APTUS Wrist 2.5 SystemHRS2015-06-09
547231815159858K142581APTUS Foot SystemHRS2015-04-09
547231401084520K141232APTUS ULNA SHORTENING 2.5HRS2014-06-23
547231331793015K133460APTUS CANNULATED COMPRESSION SCREWSHWC2013-12-18
547231349144403K120108APTUS PROXIMAL HUMERUS SYSTEMHRS2012-04-27
547231362155664K112560APTUS(R) DISTAL HUMERUS SYSTEMHRS2011-12-15
547231339916583K112169APTUS WRIST ARTHRODESIS PLATESHRS2012-01-06
547231543886548K110908APTUS FOOT 3.5 SYSTEMHRS2011-06-28
547231061568802K110658APTUS CANNULATED COMPRESSION SCREWSHWC2011-06-02
547231047027992K103332APTUS ULNA PLATESHRS2011-01-24
547231691934260K102537APTUS 1.5 TRILOCKHRS2010-12-10
547231542835718K092038APTUS K-WIRE SYSTEMHTY2009-09-23
547231701869446K091479APTUS FOOT SYSTEMHRS2009-07-13
547231885872706K090983APTUS 2.0/2.3 FOUR CORNER FUSION PLATEHRS2009-07-01
547231219861555K090053APTUS 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
547231019063960K050934MODUS TITANIUM OSTEOSYNTHESIS SYSTEMJEY2005-05-05
547231246715792
547231587128554
547231645328668
547231925549610
547231947064241
547231960801977

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS312026-03-16
HWC62026-04-17
JEY42007-09-11
JDR12019-08-16
HTY12009-09-23
DZE12005-10-21
MQN12005-08-22

PMN#

GUDID#

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