Class Class II
Cannulated PsiFGuard (K241895)
Description
Cannulated PsiFGuard by Spineguard, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241895
Clearance Date2024-09-26
Clearance TypeTraditional
Product CodeSCY
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241895
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. Cannulated PsiFGuard (K241895) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221047 | SILO TFX MIS Sacroiliac Joint Fixation System | Aurora Spine, Inc. | 2022 |
| K201454 | DSG Connect Technology | Spineguard S.A. | 2021 |
Trace the full predicate network for K241895
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.