Jeil Medical Corporation - FDA 510(k) Cleared Devices
Recent clearances: Leforte MMF System, ARIX Femur Nail System, FIX-C PEEK ACIF SA System
53
Total
53
Cleared
0
Denied
FDA 510(k) Regulatory Record - Jeil Medical Corporation Orthopedic ✕
40 devices
Cleared
Dec 10, 2025
ARIX Femur Nail System
Orthopedic
96d
Cleared
Jun 27, 2025
FIX-C PEEK ACIF SA System
Orthopedic
50d
Cleared
Jun 12, 2025
FIX-L PEEK PLIF and T-PLIF System
Orthopedic
171d
Cleared
May 30, 2025
ARIX Pectus Bar System
Orthopedic
260d
Cleared
Apr 22, 2025
ARIX Femur Nail System
Orthopedic
265d
Cleared
Feb 18, 2025
FIX-C 3D Ti ACIF System
Orthopedic
60d
Cleared
Nov 08, 2024
Xpine Spinal Fixation System
Orthopedic
43d
Cleared
Jul 24, 2024
FlexWing Anterior Cervical Plate System
Orthopedic
450d
Cleared
Mar 11, 2024
ARIX Cannulated Screw System
Orthopedic
90d
Cleared
Dec 14, 2023
ARIX Ankle Distal Tibia System
Orthopedic
170d
Cleared
Jul 17, 2023
ARIX Ankle System
Orthopedic
60d
Cleared
May 03, 2023
ARIX Humerus System
Orthopedic
30d
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