Class Class II
EVOLUTION SPINE Interbody System (K223146)
Description
EVOLUTION SPINE Interbody System by Evolution Spine, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223146
Clearance Date2023-02-07
Clearance TypeTraditional
Product CodeOVD
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223146
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. EVOLUTION SPINE Interbody System (K223146) cites 4 predicate devices and is itself cited by 3 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211496 | TransLoc 3D | Foundation Fusion Solutions, LLC (D... | 2022 |
| K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems | 2022 |
| K191391 | HEDRON Lumbar Spacers | Globus Medical, Inc. | 2019 |
| K103034 | GENESYS SPINE INTERBODY FUSION SYSTEM | Genesys Spine | 2010 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241846 | E3D-C Interbody System | Evolution Spine | 2024 |
| K240368 | E3D-A Interbody System | Evolution Spine | 2024 |
| K232432 | E3D-A Interbody System | Evolution Spine | 2024 |
Trace the full predicate network for K223146
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.