The following data is part of a premarket notification filed by Trans1 with the FDA for Trans1 Axialif Plus System.
| Device ID | K192792 |
| 510k Number | K192792 |
| Device Name: | TranS1 AxiaLIF Plus System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | TranS1 3804 Park Avenue Wilmington, NC 28403 |
| Contact | Kristen Allen |
| Correspondent | Kristen Allen TranS1 3804 Park Avenue Wilmington, NC 28403 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2019-11-20 |