The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Arix Ankle System.
| Device ID | K193616 |
| 510k Number | K193616 |
| Device Name: | ARIX Ankle System |
| Classification | Plate, Fixation, Bone |
| Applicant | Jeil Medical Corporation 702, 703, 704, 705, 706, 804, 805,807,812-ho ,55, Digital-ro34-gil, Guro-gu Seoul, KR 08378 |
| Contact | Jonghwan Kim |
| Correspondent | Jonghwan Kim Jeil Medical Corporation 702, 703, 704, 705, 706, 804, 805,807,812-ho ,55, Digital-ro34-gil, Guro-gu Seoul, KR 08378 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-26 |
| Decision Date | 2020-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809282819841 | K193616 | 000 |
| 08800089436200 | K193616 | 000 |
| 08806390886642 | K193616 | 000 |
| 08806390886659 | K193616 | 000 |
| 08806390892575 | K193616 | 000 |
| 08806390874168 | K193616 | 000 |
| 08806390874175 | K193616 | 000 |
| 08806390874182 | K193616 | 000 |
| 08806390874199 | K193616 | 000 |
| 08806390874205 | K193616 | 000 |
| 08806390874212 | K193616 | 000 |
| 08806390874229 | K193616 | 000 |
| 08806390874236 | K193616 | 000 |
| 08806390874243 | K193616 | 000 |
| 08806390874250 | K193616 | 000 |
| 08806390874267 | K193616 | 000 |
| 08806390874274 | K193616 | 000 |
| 08800089436194 | K193616 | 000 |