The following data is part of a premarket notification filed by Nexus Spine, Llc with the FDA for Tranquil Interbody System.
| Device ID | K181483 |
| 510k Number | K181483 |
| Device Name: | Tranquil Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Nexus Spine, LLC 2825 E Cottonwood Parkway, Suite 330 Salt Lake City, UT 84121 |
| Contact | Jared Crocker |
| Correspondent | Jared Crocker Nexus Spine, LLC 2825 E Cottonwood Parkway, Suite 330 Salt Lake City, UT 84121 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-05 |
| Decision Date | 2018-08-27 |
| Summary: | summary |