The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Arix Small Fragment System.
| Device ID | K221920 |
| 510k Number | K221920 |
| Device Name: | ARIX Small Fragment System |
| Classification | Plate, Fixation, Bone |
| Applicant | Jeil Medical Corporation 702, 703, 704, 705, 706, 804, 805, 807, 812, 815-ho, 55, Digital-ro 34-gil, Guro-gu Seoul, KR 08378 |
| Contact | Bora Kim |
| Correspondent | Bora Kim Jeil Medical Corporation 702, 703, 704, 705, 706, 804, 805, 807, 812, 815-ho, 55, Digital-ro 34-gil, Guro-gu Seoul, KR 08378 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-01 |
| Decision Date | 2022-08-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800089404186 | K221920 | 000 |
| 08800089404049 | K221920 | 000 |
| 08800089404087 | K221920 | 000 |
| 08800089404094 | K221920 | 000 |
| 08800089404100 | K221920 | 000 |
| 08800089404117 | K221920 | 000 |
| 08800089404124 | K221920 | 000 |
| 08800089404131 | K221920 | 000 |
| 08800089404148 | K221920 | 000 |
| 08800089404155 | K221920 | 000 |
| 08800089404162 | K221920 | 000 |
| 08800089404179 | K221920 | 000 |
| 08800089404032 | K221920 | 000 |