Class Class II
LumiVy™ Lumbar IBF System (K223412)
Description
LumiVy™ Lumbar IBF System by Vy Spine, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223412
Clearance Date2023-01-06
Clearance TypeSpecial
Product CodeMAX
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223412
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 (K223412) cites 8 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212930 | LumiVy Lumbar IBF System | Vy Spine, LLC | 2022 |
| K200879 | SeaSpine Meridian System, SeaSpine Regatta Lateral System | SeaSpine Orthopedics Corporation | 2020 |
| K193636 | SeaSpine Reef TH System | SeaSpine Orthopedics Corporation | 2020 |
| K192132 | SeaSpine Beachside System | SeaSpine Orthopedics Corporation | 2019 |
| K181079 | SeaSpine Regatta Lateral System | SeaSpine Orthopedics Corporation | 2018 |
| K173606 | SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fu... | SeaSpine Orthopedics Corporation | 2018 |
| K173260 | SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood... | SeaSpine Orthopedics Corporation | 2017 |
| K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ven... | Seaspine, Inc. | 2014 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233807 | LumiVy Lumbar IBF System | Vy Spine, LLC | 2024 |
| K230414 | ClariVy Cervical IBF System | Vy Spine, LLC | 2023 |
Trace the full predicate network for K223412
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.