The following data is part of a premarket notification filed by Trans1, Inc. with the FDA for Trans1 Axial Fixation System.
| Device ID | K040426 |
| 510k Number | K040426 |
| Device Name: | TRANS1 AXIAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | TRANS1, INC. 1800 SIR TYLER DRIVE SUITE 101 Wilmington, NC 28405 |
| Contact | Cheryl L Johns |
| Correspondent | Cheryl L Johns TRANS1, INC. 1800 SIR TYLER DRIVE SUITE 101 Wilmington, NC 28405 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-19 |
| Decision Date | 2004-12-17 |
| Summary: | summary |