FDA 510(k) Applications Submitted by Jeil Medical Corporation

FDA 510(k) Number Submission Date Device Name Applicant
K181806 07/06/2018 ARIX Sternal System Jeil Medical Corporation
K191972 07/24/2019 ARIX Wrist System Jeil Medical Corporation
K202912 09/29/2020 ARIX Ankle Distal Tibia System Jeil Medical Corporation
K230938 04/03/2023 ARIX Humerus System Jeil Medical Corporation
K221920 07/01/2022 ARIX Small Fragment System Jeil Medical Corporation
K101902 07/08/2010 J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030 JEIL MEDICAL CORPORATION
K231441 05/18/2023 ARIX Ankle System Jeil Medical Corporation
K231887 06/27/2023 ARIX Ankle Distal Tibia System Jeil Medical Corporation
K212266 07/20/2021 FIX-C PEEK Anterior Cervical Interbody System Jeil Medical Corporation
K242247 07/31/2024 ARIX Femur Nail System Jeil Medical Corporation
K243973 12/23/2024 FIX-L PEEK PLIF and T-PLIF System Jeil Medical Corporation
K050669 03/15/2005 JEIL BONE FIXATION SYSTEM JEIL MEDICAL CORPORATION
K023360 10/07/2002 LEFORTE SYSTEM BONE PLATE JEIL MEDICAL CORPORATION
K023365 10/07/2002 LEFORTE SYSTEM BONE SCREW JEIL MEDICAL CORPORATION
K033767 12/03/2003 DUAL TOP ANCHOR SYSTEM SCREWS JEIL MEDICAL CORPORATION
K242751 09/12/2024 ARIX Pectus Bar System Jeil Medical Corporation
K132876 09/13/2013 ARIX HAND LOCKING SYSTEM JEIL MEDICAL CORPORATION
K143730 12/29/2014 GBR System JEIL MEDICAL CORPORATION
K163308 11/23/2016 SMARTO JEIL MEDICAL CORPORATION
K170705 03/08/2017 ARIX Wrist System Jeil Medical Corporation
K131311 05/07/2013 ARIX FOOT SYSTEM JEIL MEDICAL CORPORATION
K131566 05/30/2013 ARIX HAND SYSTEM JEIL MEDICAL CORPORATION
K130447 02/21/2013 SPEEDY FLAP SYSTEM Jeil Medical Corporation
K150965 04/10/2015 LeForte System II Jeil Medical Corporation
K251431 05/08/2025 FIX-C PEEK ACIF SA System Jeil Medical Corporation
K233912 12/12/2023 ARIX Cannulated Screw System Jeil Medical Corporation
K243915 12/20/2024 FIX-C 3D Ti ACIF System Jeil Medical Corporation
K243004 09/26/2024 Xpine Spinal Fixation System Jeil Medical Corporation
K151468 06/01/2015 ARIX Wrist System Jeil Medical Corporation
K152158 08/03/2015 ARIX Ankle System Jeil Medical Corporation
K193616 12/26/2019 ARIX Ankle System Jeil Medical Corporation
K101563 06/04/2010 SMARTO JEIL MEDICAL CORPORATION
K112812 09/27/2011 LEFORTE NEURO SYSTEM BONE PLATE JEIL MEDICAL CORPORATION
K103778 12/27/2010 LEFORTE NEURO SYSTEM BONE PLATE JEIL MEDICAL CORPORATION
K141452 06/02/2014 LEFORTE NEURO SYSTEM BONE PLATE AND SCREW JEIL MEDICAL CORPORATION
K170313 02/01/2017 ARIX Ankle Distal Tibia System Jeil Medical Corporation
K170979 04/03/2017 ARIX Ankle Fibula Hook Plate System Jeil Medical Corporation
K231251 05/01/2023 FlexWing Anterior Cervical Plate System Jeil Medical Corporation
K221412 05/16/2022 ARIX Rib System Jeil Medical Corporation
K201656 06/18/2020 ARIX Elbow System Jeil Medical Corporation
K172008 07/03/2017 ARIX Humerus System Jeil Medical Corporation
K161864 07/07/2016 ARIX Foot System JEIL MEDICAL CORPORATION
K192417 09/04/2019 ARIX Cannulated Screw System Jeil Medical Corporation
K170368 02/06/2017 Sterile NS System Jeil Medical Corporation
K180972 04/13/2018 ARIX Clavicle System Jeil Medical Corporation
K161746 06/24/2016 ARIX Hand System Jeil Medical Corporation
K161335 05/12/2016 Dual Top Screw System JEIL MEDICAL CORPORATION
K091679 06/09/2009 LEFORTE SYSTEM BONE PLATE JEIL MEDICAL CORPORATION
K091686 06/09/2009 LEFORTE NEUROSYSTEM BONE SCREW JEIL MEDICAL CORPORATION
K170780 03/15/2017 ARIX Foot System (2.3/2.8) Jeil Medical Corporation
K171285 05/01/2017 ARIX Diaphysis System Jeil Medical Corporation


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact