Class Class II
Ventana™ C Spinal System (K222833)
Description
Ventana™ C Spinal System by Spinal Elements, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222833
Clearance Date2023-05-19
Clearance TypeTraditional
Product CodeODP
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222833
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. Ventana™ C Spinal System (K222833) cites 4 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203254 | Lucent 3D Spinal System | Spinal Elements, Inc. | 2021 |
| K200429 | BEE Cages | NGMedical GmbH | 2021 |
| K192570 | Atlas Spine Expandable Cervical Standalone Interbody System | Atlas Spine, Inc. | 2020 |
| K153352 | Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cer... | Spinal Elements, Inc. | 2016 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240416 | Tranquil-C Interbody System | Nexus Spine, LLC | 2024 |
Trace the full predicate network for K222833
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.