Class Class II
LumiVy™ Lumbar IBF System (K233807)
Description
LumiVy™ Lumbar IBF System by Vy Spine, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK233807
Clearance Date2024-09-24
Clearance TypeTraditional
Product CodeMAX
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K233807
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. LumiVy™ Lumbar IBF System (K233807) cites 7 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231836 | ClariVy™ Cervical IBF System | Vy Spine, LLC | 2023 |
| K230414 | ClariVy™ Cervical IBF System | Vy Spine, LLC | 2023 |
| K223412 | LumiVy™ Lumbar IBF System | Vy Spine, LLC | 2023 |
| K212930 | LumiVy Lumbar IBF System | Vy Spine, LLC | 2022 |
| K212715 | Vy Spine ClariVy Cervical IBF System | Vy Spine, LLC | 2021 |
| K200879 | SeaSpine Meridian System, SeaSpine Regatta Lateral System | SeaSpine Orthopedics Corporation | 2020 |
| K172343 | Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D... | Rti Surgical, Inc. | 2017 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241783 | FortiVy™ OsteoVy™ Lumbar IBF | Vy Spine, LLC | 2025 |
Trace the full predicate network for K233807
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.