The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Arix Cannulated Screw System.
| Device ID | K192417 |
| 510k Number | K192417 |
| Device Name: | ARIX Cannulated Screw System |
| Classification | Screw, 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 38378 |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-04 |
| Decision Date | 2019-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809282815690 | K192417 | 000 |
| 08806390849487 | K192417 | 000 |
| 08806390849470 | K192417 | 000 |
| 08806390849463 | K192417 | 000 |
| 08806390849456 | K192417 | 000 |
| 08806390849449 | K192417 | 000 |
| 08806390849432 | K192417 | 000 |
| 08806390849425 | K192417 | 000 |
| 08806390849418 | K192417 | 000 |
| 08806390849401 | K192417 | 000 |
| 08806390849395 | K192417 | 000 |
| 08806390849388 | K192417 | 000 |
| 08806390849371 | K192417 | 000 |
| 08806390849364 | K192417 | 000 |
| 08806390849357 | K192417 | 000 |
| 08806390849494 | K192417 | 000 |
| 08806390850742 | K192417 | 000 |
| 08806390850759 | K192417 | 000 |
| 08806390822633 | K192417 | 000 |
| 08809282815515 | K192417 | 000 |
| 08809282815508 | K192417 | 000 |
| 08806390862288 | K192417 | 000 |
| 08806390855327 | K192417 | 000 |
| 08806390855310 | K192417 | 000 |
| 08806390855303 | K192417 | 000 |
| 08806390855297 | K192417 | 000 |
| 08806390855280 | K192417 | 000 |
| 08806390855273 | K192417 | 000 |
| 08806390855266 | K192417 | 000 |
| 08806390855259 | K192417 | 000 |
| 08806390855242 | K192417 | 000 |
| 08806390855235 | K192417 | 000 |
| 08806390849340 | K192417 | 000 |