510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Jeil Medical Corporation

Seoul, KR

JEIL MEDICAL CORPORATION appears in FDA device records in Seoul, KR. FDA records list 53 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
53
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

Showing 50 of 53

FDA records hold 53 510(k) clearances for Jeil Medical Corporation between 2002 and 2026. The busiest year on record is 2017, with 8. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Jeil Medical Corporation, by decision year
YearClearances
20021
20031
20041
20051
20092
20101
20112
20121
20133
20142
20153
20164
20178
20182
20192
20203
20211
20222
20233
20243
20256
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K252246Leforte MMF SystemJEYSubstantially Equivalent
K252826ARIX Femur Nail SystemHSBSubstantially Equivalent
K251431FIX-C PEEK ACIF SA SystemOVESubstantially Equivalent
K243973FIX-L PEEK PLIF and T-PLIF SystemMAXSubstantially Equivalent
K242751ARIX Pectus Bar SystemHRSSubstantially Equivalent
K242247ARIX Femur Nail SystemHSBSubstantially Equivalent
K243915FIX-C 3D Ti ACIF SystemODPSubstantially Equivalent
K243004Xpine Spinal Fixation SystemNKBSubstantially Equivalent
K231251FlexWing Anterior Cervical Plate SystemKWQSubstantially Equivalent
K233912ARIX Cannulated Screw SystemHWCSubstantially Equivalent
K231887ARIX Ankle Distal Tibia SystemHRSSubstantially Equivalent
K231441ARIX Ankle SystemHRSSubstantially Equivalent
K230938ARIX Humerus SystemHRSSubstantially Equivalent
K221412ARIX Rib SystemHRSSubstantially Equivalent
K221920ARIX Small Fragment SystemHRSSubstantially Equivalent
K212266FIX-C PEEK Anterior Cervical Interbody SystemODPSubstantially Equivalent
K202912ARIX Ankle Distal Tibia SystemHRSSubstantially Equivalent
K201656ARIX Elbow SystemHRSSubstantially Equivalent
K193616ARIX Ankle SystemHRSSubstantially Equivalent
K192417ARIX Cannulated Screw SystemHWCSubstantially Equivalent
K191972ARIX Wrist SystemHRSSubstantially Equivalent
K181806ARIX Sternal SystemHRSSubstantially Equivalent
K180972ARIX Clavicle SystemHRSSubstantially Equivalent
K172008ARIX Humerus SystemHRSSubstantially Equivalent
K170705ARIX Wrist SystemHRSSubstantially Equivalent
K170368Sterile NS SystemGWOSubstantially Equivalent
K170979ARIX Ankle Fibula Hook Plate SystemHRSSubstantially Equivalent
K170780ARIX Foot System (2.3/2.8)HRSSubstantially Equivalent
K170313ARIX Ankle Distal Tibia SystemHRSSubstantially Equivalent
K171285ARIX Diaphysis SystemHRSSubstantially Equivalent
K161335Dual Top Screw SystemOATSubstantially Equivalent
K163308SMARTOKIJSubstantially Equivalent
K161746ARIX Hand SystemHRSSubstantially Equivalent
K161864ARIX Foot SystemHRSSubstantially Equivalent
K151468ARIX Wrist SystemHRSSubstantially Equivalent
K152158ARIX Ankle SystemKTTSubstantially Equivalent
K150965LeForte System IIJEYSubstantially Equivalent
K143730GBR SystemJEYSubstantially Equivalent
K130447SPEEDY FLAP SYSTEMGXNSubstantially Equivalent
K141452LEFORTE NEURO SYSTEM BONE PLATE AND SCREWGWOSubstantially Equivalent
K132876ARIX HAND LOCKING SYSTEMHRSSubstantially Equivalent
K131566ARIX HAND SYSTEMHRSSubstantially Equivalent
K131311ARIX FOOT SYSTEMHRSSubstantially Equivalent
K112812LEFORTE NEURO SYSTEM BONE PLATEGWOSubstantially Equivalent
K101902J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030DZLSubstantially Equivalent
K103778LEFORTE NEURO SYSTEM BONE PLATEJEYSubstantially Equivalent
K101563SMARTOKIJSubstantially Equivalent
K091686LEFORTE NEUROSYSTEM BONE SCREWHWCSubstantially Equivalent
K091679LEFORTE SYSTEM BONE PLATEJEYSubstantially Equivalent
K050669JEIL BONE FIXATION SYSTEMJEYSubstantially Equivalent

Registered establishments

FDA registered establishments for Jeil Medical Corporation, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30040499233004049923JEIL MEDICAL CORPORATION702,703,704,705,706,707,804,805,807,812,815-ho, Seoul 08378 KR2026and 50 more, listed in full below
30149371013014937101JEIL MEDICAL CORPORATION380, Beoman-ro, Siheung-si Gyeonggi 14928 KR2026and 3 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain