Jeil Medical Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 52
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252826 | ARIX Femur Nail System | December 10, 2025 |
| K251431 | FIX-C PEEK ACIF SA System | June 27, 2025 |
| K243973 | FIX-L PEEK PLIF and T-PLIF System | June 12, 2025 |
| K242751 | ARIX Pectus Bar System | May 30, 2025 |
| K242247 | ARIX Femur Nail System | April 22, 2025 |
| K243915 | FIX-C 3D Ti ACIF System | February 18, 2025 |
| K243004 | Xpine Spinal Fixation System | November 8, 2024 |
| K231251 | FlexWing Anterior Cervical Plate System | July 24, 2024 |
| K233912 | ARIX Cannulated Screw System | March 11, 2024 |
| K231887 | ARIX Ankle Distal Tibia System | December 14, 2023 |
| K231441 | ARIX Ankle System | July 17, 2023 |
| K230938 | ARIX Humerus System | May 3, 2023 |
| K221412 | ARIX Rib System | November 22, 2022 |
| K221920 | ARIX Small Fragment System | August 24, 2022 |
| K212266 | FIX-C PEEK Anterior Cervical Interbody System | December 21, 2021 |
| K202912 | ARIX Ankle Distal Tibia System | October 29, 2020 |
| K201656 | ARIX Elbow System | September 15, 2020 |
| K193616 | ARIX Ankle System | March 4, 2020 |
| K192417 | ARIX Cannulated Screw System | November 26, 2019 |
| K191972 | ARIX Wrist System | November 12, 2019 |