Class Class II
VySpan™ PCT System (K223852)
Description
VySpan™ PCT System by Vy Spine, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223852
Clearance Date2023-02-24
Clearance TypeSpecial
Product CodeNKG
Regulation Number888.3075
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223852
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. VySpan™ PCT System (K223852) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213394 | Vy Spine VySpan PCT System | Vy Spine, LLC | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232167 | VySpan PCT System | Vy Spine, LLC | 2023 |
Trace the full predicate network for K223852
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.