Class Class II
Eminent Spine 3D Lumbar Interbody Fusion Systems (K230219)
Description
Eminent Spine 3D Lumbar Interbody Fusion Systems by Eminent Spine, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230219
Clearance Date2023-05-16
Clearance TypeTraditional
Product CodeMAX
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230219
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Eminent Spine 3D Lumbar Interbody Fusion Systems (K230219) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212701 | Eminent Spine 3D Cervical Interbody Fusion System | Eminent Spine | 2023 |
| K190364 | CancelleX Porous Titanium Lumbar Interbody Device | Xenco Medical, LLC | 2019 |
| K090064 | EMINENT SPINE INTERBODY FUSION SYSTEM | Eminent Spine | 2009 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243074 | Spectrum Spine Lumbar Cage System | Spectrum Spine, Inc. | 2025 |
Trace the full predicate network for K230219
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.