Class Class II
ClariVy™ Cervical IBF System (K230414)
Description
ClariVy™ Cervical IBF System by Vy Spine, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230414
Clearance Date2023-05-12
Clearance TypeSpecial
Product CodeODP
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230414
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. ClariVy™ Cervical IBF System (K230414) cites 2 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223412 | LumiVy Lumbar IBF System | Vy Spine, LLC | 2023 |
| K212715 | Vy Spine ClariVy Cervical IBF System | Vy Spine, LLC | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233807 | LumiVy Lumbar IBF System | Vy Spine, LLC | 2024 |
| K231836 | ClariVy Cervical IBF System | Vy Spine, LLC | 2023 |
Trace the full predicate network for K230414
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.