The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Arix Foot System.
| Device ID | K131311 |
| 510k Number | K131311 |
| Device Name: | ARIX FOOT SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | JEIL MEDICAL CORPORATION #702, KOLON SCIENCE VALLEY 2ND 811, GURO-DONG, GURO-GU Seoul-city, KR 152-050 |
| Contact | Ji-eun Kim |
| Correspondent | Ji-eun Kim JEIL MEDICAL CORPORATION #702, KOLON SCIENCE VALLEY 2ND 811, GURO-DONG, GURO-GU Seoul-city, KR 152-050 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-07 |
| Decision Date | 2013-09-05 |
| Summary: | summary |