Company ยท KR
Jeil Medical Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2026. Name variants (Inc, Corp, punctuation) are merged.
53510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HRS | Plate, Fixation, Bone | 24 |
| JEY | Plate, Bone | 6 |
| HWC | Screw, Fixation, Bone | 4 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | 3 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 2 |
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 |
| DZE | Implant, Endosseous, Root-Form | 1 |
| DZL | Screw, Fixation, Intraosseous | 1 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 |
| OAT | Implant, Endosseous, Orthodontic | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 2, 2026 | K252246 | Leforte MMF System Jeil Medical Corporation, KR | JEY |
| Dec 10, 2025 | K252826 | ARIX Femur Nail System Jeil Medical Corporation, KR | HSB |
| Jun 27, 2025 | K251431 | FIX-C PEEK ACIF SA System Jeil Medical Corporation, KR | OVE |
| Jun 12, 2025 | K243973 | FIX-L PEEK PLIF and T-PLIF System Jeil Medical Corporation, KR | MAX |
| May 30, 2025 | K242751 | ARIX Pectus Bar System Jeil Medical Corporation, KR | HRS |
| Apr 22, 2025 | K242247 | ARIX Femur Nail System Jeil Medical Corporation, KR | HSB |
| Feb 18, 2025 | K243915 | FIX-C 3D Ti ACIF System Jeil Medical Corporation, KR | ODP |
| Nov 8, 2024 | K243004 | Xpine Spinal Fixation System Jeil Medical Corporation, KR | NKB |
| Jul 24, 2024 | K231251 | FlexWing Anterior Cervical Plate System Jeil Medical Corporation, KR | KWQ |
| Mar 11, 2024 | K233912 | ARIX Cannulated Screw System Jeil Medical Corporation, KR | HWC |
| Dec 14, 2023 | K231887 | ARIX Ankle Distal Tibia System Jeil Medical Corporation, KR | HRS |
| Jul 17, 2023 | K231441 | ARIX Ankle System Jeil Medical Corporation, KR | HRS |
| May 3, 2023 | K230938 | ARIX Humerus System Jeil Medical Corporation, KR | HRS |
| Nov 22, 2022 | K221412 | ARIX Rib System Jeil Medical Corporation, KR | HRS |
| Aug 24, 2022 | K221920 | ARIX Small Fragment System Jeil Medical Corporation, KR | HRS |
| Dec 21, 2021 | K212266 | FIX-C PEEK Anterior Cervical Interbody System Jeil Medical Corporation, KR | ODP |
| Oct 29, 2020 | K202912 | ARIX Ankle Distal Tibia System Jeil Medical Corporation, KR | HRS |
| Sep 15, 2020 | K201656 | ARIX Elbow System Jeil Medical Corporation, KR | HRS |
| Mar 4, 2020 | K193616 | ARIX Ankle System Jeil Medical Corporation, KR | HRS |
| Nov 26, 2019 | K192417 | ARIX Cannulated Screw System Jeil Medical Corporation, KR | HWC |
| Nov 12, 2019 | K191972 | ARIX Wrist System Jeil Medical Corporation, KR | HRS |
| Nov 20, 2018 | K181806 | ARIX Sternal System Jeil Medical Corporation, KR | HRS |
| Oct 3, 2018 | K180972 | ARIX Clavicle System Jeil Medical Corporation, KR | HRS |
| Dec 1, 2017 | K172008 | ARIX Humerus System Jeil Medical Corporation, KR | HRS |
| Sep 21, 2017 | K170705 | ARIX Wrist System Jeil Medical Corporation, KR | HRS |
| Sep 11, 2017 | K170368 | Sterile NS System Jeil Medical Corporation, KR | GWO |
| Aug 17, 2017 | K170979 | ARIX Ankle Fibula Hook Plate System Jeil Medical Corporation, KR | HRS |
| Aug 14, 2017 | K170780 | ARIX Foot System (2.3/2.8) Jeil Medical Corporation, KR | HRS |
| Jul 27, 2017 | K170313 | ARIX Ankle Distal Tibia System Jeil Medical Corporation, KR | HRS |
| Jul 24, 2017 | K171285 | ARIX Diaphysis System Jeil Medical Corporation, KR | HRS |
| Feb 23, 2017 | K161335 | Dual Top Screw System Jeil Medical Corporation, KR | OAT |
| Dec 27, 2016 | K163308 | SMARTO Jeil Medical Corporation, KR | KIJ |
| Sep 21, 2016 | K161746 | ARIX Hand System Jeil Medical Corporation, KR | HRS |
| Aug 2, 2016 | K161864 | ARIX Foot System Jeil Medical Corporation, KR | HRS |
| Jan 14, 2016 | K151468 | ARIX Wrist System Jeil Medical Corporation, KR | HRS |
| Sep 28, 2015 | K152158 | ARIX Ankle System Jeil Medical Corporation, KR | KTT |
| Sep 17, 2015 | K150965 | LeForte System II Jeil Medical Corporation, KR | JEY |
| Jun 10, 2015 | K143730 | GBR System Jeil Medical Corporation, KR | JEY |
| Dec 22, 2014 | K130447 | SPEEDY FLAP SYSTEM Jeil Medical Corporation, KR | GXN |
| Jul 2, 2014 | K141452 | LEFORTE NEURO SYSTEM BONE PLATE AND SCREW Jeil Medical Corporation | GWO |
| Dec 18, 2013 | K132876 | ARIX HAND LOCKING SYSTEM Jeil Medical Corporation, KR | HRS |
| Nov 4, 2013 | K131566 | ARIX HAND SYSTEM Jeil Medical Corporation, KR | HRS |
| Sep 5, 2013 | K131311 | ARIX FOOT SYSTEM Jeil Medical Corporation, KR | HRS |
| Feb 22, 2012 | K112812 | LEFORTE NEURO SYSTEM BONE PLATE Jeil Medical Corporation | GWO |
| Feb 8, 2011 | K101902 | J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030 Jeil Medical Corporation | DZL |
| Jan 26, 2011 | K103778 | LEFORTE NEURO SYSTEM BONE PLATE Jeil Medical Corporation | JEY |
| Dec 17, 2010 | K101563 | SMARTO Jeil Medical Corporation, KR | KIJ |
| Nov 13, 2009 | K091686 | LEFORTE NEUROSYSTEM BONE SCREW Jeil Medical Corporation | HWC |
| Oct 2, 2009 | K091679 | LEFORTE SYSTEM BONE PLATE Jeil Medical Corporation | JEY |
| May 26, 2005 | K050669 | JEIL BONE FIXATION SYSTEM Jeil Medical Corporation | JEY |
Newest 50 of 53.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||