The following data is part of a premarket notification filed by Trans1 with the FDA for Trans1 Interbody Fusion System.
| Device ID | K191791 |
| 510k Number | K191791 |
| Device Name: | TranS1 Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | TranS1 3804 Park Avenue, Suite C Wilmington, NC 28403 |
| Contact | Kristen Allen |
| Correspondent | Kristen Allen TranS1 3804 Park Avenue, Suite C Wilmington, NC 28403 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-03 |
| Decision Date | 2019-09-25 |
| Summary: | summary |