The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Arix Ankle Distal Tibia System.
| Device ID | K170313 |
| 510k Number | K170313 |
| Device Name: | ARIX Ankle Distal Tibia System |
| Classification | Plate, Fixation, Bone |
| Applicant | Jeil Medical Corporation #702, Kolon Science Valley 2nd 55, Digital-ro 34, Guro-gu Seoul, KR 152-728 |
| Contact | Sejin Ryu |
| Correspondent | Sejin Ryu Jeil Medical Corporation #702, Kolon Science Valley 2nd 55, Digital-ro 34, Guro-gu Seoul, KR 152-728 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-01 |
| Decision Date | 2017-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806390884785 | K170313 | 000 |
| 08800089403790 | K170313 | 000 |
| 08800089403806 | K170313 | 000 |
| 08800089403813 | K170313 | 000 |
| 08800089403820 | K170313 | 000 |
| 08806390883474 | K170313 | 000 |
| 08806390878449 | K170313 | 000 |
| 08806390878456 | K170313 | 000 |
| 08806390878463 | K170313 | 000 |
| 08806390878470 | K170313 | 000 |
| 08806390878487 | K170313 | 000 |
| 08806390879118 | K170313 | 000 |
| 08806390879125 | K170313 | 000 |
| 08800089402113 | K170313 | 000 |