The following data is part of a premarket notification filed by Trans1 Incorporated with the FDA for Trans1 Axial Fixaton System.
| Device ID | K073514 |
| 510k Number | K073514 |
| Device Name: | TRANS1 AXIAL FIXATON SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | TRANS1 INCORPORATED 411 LANDMARK DR. Wilmington, NC 28412 |
| Contact | William Jackson |
| Correspondent | William Jackson TRANS1 INCORPORATED 411 LANDMARK DR. Wilmington, NC 28412 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-14 |
| Decision Date | 2008-01-11 |
| Summary: | summary |