The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Arix Rib System.
| Device ID | K221412 |
| 510k Number | K221412 |
| Device Name: | ARIX Rib 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 | Sejin Ryu |
| Correspondent | Sejin Ryu 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 | 2022-05-16 |
| Decision Date | 2022-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806390880541 | K221412 | 000 |
| 08806390880374 | K221412 | 000 |
| 08806390880367 | K221412 | 000 |
| 08806390880350 | K221412 | 000 |
| 08800089434152 | K221412 | 000 |
| 08800089434145 | K221412 | 000 |
| 08800089434138 | K221412 | 000 |
| 08800089436880 | K221412 | 000 |
| 08800089436873 | K221412 | 000 |
| 08806390880398 | K221412 | 000 |
| 08806390880404 | K221412 | 000 |
| 08806390880534 | K221412 | 000 |
| 08806390880527 | K221412 | 000 |
| 08806390880510 | K221412 | 000 |
| 08806390880503 | K221412 | 000 |
| 08806390880497 | K221412 | 000 |
| 08806390880480 | K221412 | 000 |
| 08806390880381 | K221412 | 000 |
| 08806390880411 | K221412 | 000 |
| 08800089434169 | K221412 | 000 |