The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Arix Ankle Fibula Hook Plate System.
| Device ID | K170979 |
| 510k Number | K170979 |
| Device Name: | ARIX Ankle Fibula Hook Plate 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 #702,703,704,705,706,804,805,807,812-ho,55 Digital-ro34-gil, Guro-gu, Seoul 152-728 KR |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-03 |
| Decision Date | 2017-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806390898003 | K170979 | 000 |
| 08806390897990 | K170979 | 000 |
| 08806390868112 | K170979 | 000 |
| 08806390868105 | K170979 | 000 |
| 08806390852012 | K170979 | 000 |
| 08806390852005 | K170979 | 000 |