FDA.reportPublic FDA data

Medartis Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30095407493009540749Medartis Inc.1Y2027-01-011195 Polk Drive Warsaw IN US 46582

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3093712021617865P240020TOUCH® CMC 1 ProsthesisSFA2025-07-10
3093711164514145K260761APTUS Clavicle System 2.8HRS2026-06-05
3093711860272886K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5HRS2026-03-16
3093711056386253K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonHRS2025-03-07
3093711354065185K240613APTUS Elbow Dorsal Olecranon PlatesHRS2024-06-20
3093711368569290K232324StealthFix Intraosseous Fixation SystemJDR2023-08-30
3093711707440951K220181StealthFix Intraosseous Fixation SystemJDR2022-03-22
3093711401906119K212979CalcShift™ Displacement Calcaneal Osteotomy SystemHRS2022-05-20
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
3093711832202542K193639APTUS® Foot 2.8-3.5 SystemHRS2020-03-26
3093711688000254K193633APTUS® Ankle Trauma System 2.8/3.5HRS2020-03-26
3093711426760320K193554APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemHRS2020-02-16
3093711596752490K192984APTUS Clavicle SystemHRS2020-01-24
3093711306168001K192754Avenger Radial Head SystemKWI2020-01-07
3093711109629818K192297APTUS Wrist Arthrodesis PlatesHRS2019-11-08
3093711019149188K191636APTUS Foot SystemJDR2019-08-16
3093711221730796K181425APTUS® Proximal Humerus SystemHRS2018-08-05
3093711013714097K181009APTUS CMC-I Fusion Plate SystemHRS2018-08-24
3093711418771336K180348Field Orthopaedics Micro Screw SystemHWC2018-07-17
3093711679043833K172170APTUS(R) Wrist 2.5 SystemHRS2017-09-08
3093711741901141K163440Stealth Staple SystemJDR2017-02-01
3093711346804098K161861APTUS® Coronoid 2.0HRS2017-02-09
3093711356584336K153622First Ray Internal Bone Staple SystemJDR2016-04-08
3093711212797734K142906APTUS Wrist 2.5 SystemHRS2015-06-09
3093711815159858K142581APTUS Foot SystemHRS2015-04-09
3093711401084520K141232APTUS ULNA SHORTENING 2.5HRS2014-06-23
3093711331793015K133460APTUS CANNULATED COMPRESSION SCREWSHWC2013-12-18
3093711349144403K120108APTUS PROXIMAL HUMERUS SYSTEMHRS2012-04-27
3093711362155664K112560APTUS(R) DISTAL HUMERUS SYSTEMHRS2011-12-15
3093711339916583K112169APTUS WRIST ARTHRODESIS PLATESHRS2012-01-06
3093711543886548K110908APTUS FOOT 3.5 SYSTEMHRS2011-06-28
3093711061568802K110658APTUS CANNULATED COMPRESSION SCREWSHWC2011-06-02
3093711047027992K103332APTUS ULNA PLATESHRS2011-01-24
3093711691934260K102537APTUS 1.5 TRILOCKHRS2010-12-10
3093711542835718K092038APTUS K-WIRE SYSTEMHTY2009-09-23
3093711701869446K091479APTUS FOOT SYSTEMHRS2009-07-13
3093711885872706K090983APTUS 2.0/2.3 FOUR CORNER FUSION PLATEHRS2009-07-01
3093711219861555K090053APTUS 2.0 RADIAL HEAD SYSTEMHRS2009-04-23
3093711568068573K051567APTUS TITANIUM OSTEOSYNTHESIS SYSTEMHRS2005-08-23
3093711031951465
3093711086672818
3093711100362001
3093711117611488
3093711133894504
3093711246715792
3093711301898362
3093711302976132
3093711314003268
3093711321133318
3093711327422197
3093711329115803
3093711339417164
3093711356845916
3093711359481101
3093711376687087
3093711380842147
3093711510274281
3093711534057021
3093711558983000
3093711581343151
3093711587128554
3093711591492296
3093711618999269
3093711629270302
3093711645328668
3093711656878899
3093711661452742
3093711680025560
3093711692692241
3093711856009090
3093711860588227
3093711893310800
3093711919888528
3093711934615231
3093711947064241
3093711960801977
3093712065490832

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS282026-06-05
JDR52023-08-30
HWC42020-11-06
KWI22020-01-07
HTY12009-09-23

GUDID#

200 records. Showing 1-40. Next