XeliteMed VertehighFix High Viscosity Spinal Bone Cement (K241775)
Description
XeliteMed VertehighFix High Viscosity Spinal Bone Cement by Xelite Biomed , Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241775
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. XeliteMed VertehighFix High Viscosity Spinal Bone Cement (K241775) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K042415 | MENDEC SPINE | Tecres S.P.A. | 2005 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243537 | XeliteMed VertehighFix High Viscosity Spinal Bone Cement Sy... | Xelite Biomed , Ltd. | 2025 |
Trace the full predicate network for K241775
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.