# Jeil Medical Corporation

- Location (FDA's records): Seoul, KR
- FDA decisions: 53 (2002–2026): 53 510(k) clearances
- Product codes: HRS (24), JEY (6), HWC (4), GWO (3), ODP (2), HSB (2), KIJ (2), MAX (1), KWQ (1), GXN (1), OAT (1), KTT (1)
- 510(k) review time since 2016: median 124 days, against 109 for FDA's reviews in the same codes and years (13 of 32 faster)
- Predicates its devices cite: 118 (41 its own); citations of its devices by later devices: 82 (41 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 15 (https://510kreport.com/company/synthes-usa)
- Howmedica Osteonics Corp.: 8 (https://510kreport.com/company/howmedica-osteonics)
- Medartis AG: 6 (https://510kreport.com/company/medartis)
- Biomet Microfixation: 5 (https://510kreport.com/company/biomet-microfixation)
- Arkin Consulting Group: 3 (https://510kreport.com/company/arkin-consulting-group)
- Aesculap, Inc.: 3 (https://510kreport.com/company/aesculap)
- Stryker Corp.: 3 (https://510kreport.com/company/stryker)
- Arthrex, Inc.: 3 (https://510kreport.com/company/arthrex)

## Firms that cite its devices most
- Extremity Medical, LLC: 4 (https://510kreport.com/company/extremity-medical)
- Arkin Consulting Group: 3 (https://510kreport.com/company/arkin-consulting-group)
- Osstem Implant Co., Ltd.: 2 (https://510kreport.com/company/osstem-implant)
- Osteonic Co., Ltd.: 2 (https://510kreport.com/company/osteonic)
- Dentaurum: 2 (https://510kreport.com/company/dentaurum)
- Hdc Corp.: 2 (https://510kreport.com/company/hdc)
- Techwin Co., Ltd.: 1 (https://510kreport.com/company/techwin)
- Micerium S.P.A.: 1 (https://510kreport.com/company/micerium)

## Its most-cited devices
- K033767: Dual Top Anchor System Screws (2004), cited by 17
- K112812: Leforte Neuro System Bone Plate (2012), cited by 4
- K212266: FIX-C PEEK Anterior Cervical Interbody System (2021), cited by 4
- K131311: Arix Foot System (2013), cited by 3
- K131566: Arix Hand System (2013), cited by 3
- K023365: Leforte System Bone Screw (2003), cited by 3

## Recent decisions
- K252246: Leforte MMF System (Apr 2, 2026)
- K252826: ARIX Femur Nail System (Dec 10, 2025)
- K251431: FIX-C PEEK ACIF SA System (Jun 27, 2025)
- K243973: FIX-L PEEK PLIF and T-PLIF System (Jun 12, 2025)
- K242751: ARIX Pectus Bar System (May 30, 2025)
- K242247: ARIX Femur Nail System (Apr 22, 2025)
- K243915: FIX-C 3D Ti ACIF System (Feb 18, 2025)
- K243004: Xpine Spinal Fixation System (Nov 8, 2024)

Source page: https://510kreport.com/company/jeil-medical