Class Class II
Vy Spine™ VyLam™ Laminoplasty System (K242784)
Description
Vy Spine™ VyLam™ Laminoplasty System by Vy Spine, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242784
Clearance Date2024-10-16
Clearance TypeSpecial
Product CodeNQW
Regulation Number888.3050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242784
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. Vy Spine™ VyLam™ Laminoplasty System (K242784) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232471 | Vy Spine VyLam Laminoplasty System | Vy Spine, LLC | 2023 |
| K050082 | CENTERPIECE PLATE FIXATION SYSTEM | Medtronic Sofamor Danek, Inc. | 2005 |
Trace the full predicate network for K242784
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.