The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Arix Ankle System.
| Device ID | K152158 |
| 510k Number | K152158 |
| Device Name: | ARIX Ankle System |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | Jeil Medical Corporation 702, 703, 704, 705, 706, 804, 805,807,812-ho ,55, Digital-ro34-gil, Guro-gu Seoul-city, KR 152-728 |
| Contact | Jiwon Kang |
| Correspondent | Jiwon Kang Jeil Medical Corporation 702, 703, 704, 705, 706, 804, 805,807,812-ho ,55, Digital-ro34-gil, Guro-gu Seoul-city, KR 152-728 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-03 |
| Decision Date | 2015-09-28 |
| Summary: | summary |