Eminent Spine 3D Lumbar Interbody Fusion Systems
FDA 510(k) K230219 · Eminent Spine, LLC
510(k) numberK230219
Submission
- Device name
- Eminent Spine 3D Lumbar Interbody Fusion Systems
- Applicant
- Eminent Spine, LLC
Plano, TX, US - Received
- January 26, 2023
- Decision date
- May 16, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K250894 | Eminent Spine Posterior SI SystemOUR · Traditional | 10/07/2025SE |
| K241663 | Eminent Spine 3D Titanium Pedicle Screw SystemNKB · Traditional | 04/28/2025SE |
| K242069 | Eminent Spine Scoliosis Deformity Pedicle Screw SystemNKB · Special | 09/03/2024SE |
| K240505 | Eminent Spine SI Screw SystemOUR · Traditional | 06/04/2024SE |
| K212701 | Eminent Spine 3D Cervical Interbody Fusion SystemODP · Traditional | 02/06/2023SE |
| K221936 | Standalone ALIF Interbody Fusion SystemOVD · Traditional | 10/17/2022SE |
| K212853 | Cervical Stand-Alone SystemOVE · Traditional | 11/05/2021SE |
| K201979 | Cervical Plate SystemKWQ · Traditional | 08/25/2020SE |
| K143365 | Eminent Foot Plate SystemHRS · Traditional | 03/30/2015SE |
| K133194 | Diamond Rattlesnake SystemKWQ · Traditional | 06/26/2014SE |
Questions and answers
When was Eminent Spine 3D Lumbar Interbody Fusion Systems cleared by the FDA?
Eminent Spine 3D Lumbar Interbody Fusion Systems (K230219) received a 510(k) decision of Substantially Equivalent on May 16, 2023, 110 days after the submission was received.
What is the product code of K230219?
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.