Tranquil-L Interbody System
FDA 510(k) K233375 · Nexus Spine, LLC
510(k) numberK233375
Submission
- Device name
- Tranquil-L Interbody System
- Applicant
- Nexus Spine, LLC
Salt Lake City, UT, US - Received
- October 2, 2023
- Decision date
- March 20, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Other 510(k)s with product code MAX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261049 | Scala® TLMAX · Traditional | Spineart SA | 08/20/2026SE |
| K261430 | TruLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 07/28/2026SE |
| K253011 | Catalyft PL Expandable Interbody SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/17/2026SE |
| K261020 | Symmetrix L Spinal SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/14/2026SE |
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional | SeaSpine Orthopedics Corporation | 07/01/2026SE |
| K253151 | Fule Interbody Fusion Cage SystemMAX · Traditional | Beijing Fule Science & Technology Development… | 06/15/2026SE |
| K261159 | Exceed® Biplanar Expandable Interbody SystemMAX · Traditional | Spine Wave, Inc. | 05/29/2026SE |
| K253894 | BMD Titanium Spinal Fusion SystemMAX · Traditional | Global Biomedica s.r.o. | 05/28/2026SE |
| K260506 | Ventana® P/T Lumbar Interbody SystemMAX · Traditional | Spinal Elements, Inc. | 05/15/2026SE |
| K260837 | VersaLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 05/12/2026SE |
More from Life Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261279 | DeltaNEC Interbody SystemOVE · Traditional | 06/22/2026SE |
| K253331 | PressON Spinal Fixation SystemNKB · Special | 10/14/2025SE |
| K243934 | Stable-L Lumbar Interbody SystemOVD · Traditional | 04/30/2025SE |
| K241467 | Stable-C Interbody SystemOVE · Traditional | 07/17/2024SE |
| K240416 | Tranquil-C Interbody SystemODP · Special | 03/12/2024SE |
| K233234 | PressON Spinal Fixation SystemNKB · Special | 10/26/2023SE |
| K231486 | Stable-L Standalone Lumbar Interbody SystemOVD · Traditional | 10/12/2023SE |
| K232530 | Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemOVD · Special | 09/18/2023SE |
| K231763 | Stable-C Interbody SystemOVE · Traditional | 08/21/2023SE |
| K223529 | PressON Spinal Fixation SystemNKB · Traditional | 05/02/2023SE |
Questions and answers
When was Tranquil-L Interbody System cleared by the FDA?
Tranquil-L Interbody System (K233375) received a 510(k) decision of Substantially Equivalent on March 20, 2024, 170 days after the submission was received.
What is the product code of K233375?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.