The following data is part of a premarket notification filed by Trans1 Incorporated with the FDA for Trans1 Interbody Fusion System.
| Device ID | K120991 |
| 510k Number | K120991 |
| Device Name: | TRANS1 INTERBODY FUSION SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | TRANS1 INCORPORATED 301 Government Center Dr Suite 100 Wilmington, NC 28403 |
| Contact | Cheryl L Wagoner |
| Correspondent | Cheryl L Wagoner TRANS1 INCORPORATED 301 Government Center Dr Suite 100 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 | 2012-04-02 |
| Decision Date | 2012-08-23 |
| Summary: | summary |