The following data is part of a premarket notification filed by Tides Medical with the FDA for Bluefin Interbody System.
| Device ID | K143479 |
| 510k Number | K143479 |
| Device Name: | Bluefin Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Tides Medical 1819 W. Pinhook Road Suite 109 Lafayette, LA 70508 |
| Contact | J. Doug Payne |
| Correspondent | J. Doug Payne Tides Medical 1819 W. Pinhook Road Suite 109 Lafayette, LA 70508 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-08 |
| Decision Date | 2015-09-25 |
| Summary: | summary |