FDA.reportPublic FDA data

JEIL MEDICAL CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30149371013014937101JEIL MEDICAL CORPORATION1N2026-01-01380, Beoman-ro Siheung-si Gyeonggi KR 14928

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2233692068762822K252246Leforte MMF SystemJEY2026-04-02
2233691214919055K251431FIX-C PEEK ACIF SA SystemOVE2025-06-27
2233691619078251K243973FIX-L PEEK PLIF and T-PLIF SystemMAX2025-06-12
2233691017561699K243004Xpine Spinal Fixation SystemNKB2024-11-08
2233691603298750K242751ARIX Pectus Bar SystemHRS2025-05-30
2233691323010228K231887ARIX Ankle Distal Tibia SystemHRS2023-12-14
2233691952973315K231441ARIX Ankle SystemHRS2023-07-17
2233691838568522K231251FlexWing Anterior Cervical Plate SystemKWQ2024-07-24
2233691060077949K230938ARIX Humerus SystemHRS2023-05-03
2233691820487548K221920ARIX Small Fragment SystemHRS2022-08-24
2233691335066977K221412ARIX Rib SystemHRS2022-11-22
2233691596239114K212266FIX-C PEEK Anterior Cervical Interbody SystemODP2021-12-21
2233691017929341K202912ARIX Ankle Distal Tibia SystemHRS2020-10-29
2233691882370658K201656ARIX Elbow SystemHRS2020-09-15
2233692046785522K193616ARIX Ankle SystemHRS2020-03-04
2233691801611125K191972ARIX Wrist SystemHRS2019-11-12
2233691478631550K181806ARIX Sternal SystemHRS2018-11-20
2233692068906243K180972ARIX Clavicle SystemHRS2018-10-03
2233691850812710K172008ARIX Humerus SystemHRS2017-12-01
2233691935183013K171285ARIX Diaphysis SystemHRS2017-07-24
2233691437254819K170979ARIX Ankle Fibula Hook Plate SystemHRS2017-08-17
2233691026771094K170780ARIX Foot System (2.3/2.8)HRS2017-08-14
2233691830489377K170705ARIX Wrist SystemHRS2017-09-21
2233691217182365K170313ARIX Ankle Distal Tibia SystemHRS2017-07-27
2233691608198355K161864ARIX Foot SystemHRS2016-08-02
2233691586588645K161746ARIX Hand SystemHRS2016-09-21
2233691437885155K152158ARIX Ankle SystemKTT2015-09-28
2233691167293109K151468ARIX Wrist SystemHRS2016-01-14
2233691829932105K143730GBR SystemJEY2015-06-10
2233691374108219K132876ARIX HAND LOCKING SYSTEMHRS2013-12-18
2233691342104018K131566ARIX HAND SYSTEMHRS2013-11-04
2233691892554481K131311ARIX FOOT SYSTEMHRS2013-09-05
2233691170342054K130447SPEEDY FLAP SYSTEMGXN2014-12-22
2233691875690052K050669JEIL BONE FIXATION SYSTEMJEY2005-05-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS242025-05-30
JEY32026-04-02
OVE12025-06-27
MAX12025-06-12
NKB12024-11-08
KWQ12024-07-24
ODP12021-12-21
KTT12015-09-28
GXN12014-12-22

PMN#

SMARTO

2016-12-27

JEIL MEDICAL CORPORATION

52 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next