Class Class II
Stable-L Lumbar Interbody System (K243934)
Description
Stable-L Lumbar Interbody System by Nexus Spine, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243934
Clearance Date2025-04-30
Clearance TypeTraditional
Product CodeOVD
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243934
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. Stable-L Lumbar Interbody System (K243934) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241467 | Stable-C Interbody System | Nexus Spine, LLC | 2024 |
| K233966 | Anterior Spine Truss System-Stand Alone (ASTS-SA) | 4Web Medical, Inc. | 2024 |
| K231486 | Stable-L Standalone Lumbar Interbody System | Nexus Spine, LLC | 2023 |
| K232530 | Stable-L Standalone Lumbar Interbody System, Stable-C Inter... | Nexus Spine, LLC | 2023 |
Trace the full predicate network for K243934
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.