Class Class II
E3D™-C Interbody System (K241846)
Description
E3D™-C Interbody System by Evolution Spine, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241846
Clearance Date2024-08-12
Clearance TypeTraditional
Product CodeOVE
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241846
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. E3D™-C Interbody System (K241846) cites 6 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240368 | E3D-A Interbody System | Evolution Spine | 2024 |
| K232432 | E3D-A Interbody System | Evolution Spine | 2024 |
| K223146 | EVOLUTION SPINE Interbody System | Evolution Spine | 2023 |
| K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expan... | Globus Medical, Inc. | 2022 |
| K191477 | AEON-C Stand Alone System | Huvexel Co. , Ltd. | 2019 |
| K151939 | COALITION Spacers | Globus Medical, Inc. | 2016 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K254105 | Hive Standalone Cervical System and Hive C Interbody System | NanoHive Medical, LLC | 2026 |
Trace the full predicate network for K241846
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.