The following data is part of a premarket notification filed by Truabutment Inc. with the FDA for Uris Omni Narrow System & Prosthetic.
| Device ID | K200817 |
| 510k Number | K200817 |
| Device Name: | URIS OMNI Narrow System & Prosthetic |
| Classification | Implant, Endosseous, Root-form |
| Applicant | TruAbutment Inc. 17742 Cowan Irvine, CA 92614 |
| Contact | Eunjin Jang |
| Correspondent | Chris Choi TruAbutment Inc. 17742 Cowan Irvine, CA 92614 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-30 |
| Decision Date | 2020-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800076400443 | K200817 | 000 |
| 08800076400436 | K200817 | 000 |
| 08800076400429 | K200817 | 000 |
| 08800076400412 | K200817 | 000 |
| 08800076400047 | K200817 | 000 |
| 08800076400030 | K200817 | 000 |
| 08800076400023 | K200817 | 000 |
| 08800076400016 | K200817 | 000 |