The following data is part of a premarket notification filed by Trans1 Incorporated with the FDA for Axialif 2l, Axialif 2-level System, Axialif Apollo, Axialif Ii.
| Device ID | K092124 |
| 510k Number | K092124 |
| Device Name: | AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | TRANS1 INCORPORATED 411 LANDMARK DR. Wilmington, NC 28412 |
| Contact | Cheryl Wagoner |
| Correspondent | Cheryl Wagoner TRANS1 INCORPORATED 411 LANDMARK DR. Wilmington, NC 28412 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-15 |
| Decision Date | 2010-01-21 |
| Summary: | summary |