Class Class II
xvision Spine System (K241481)
Description
xvision Spine System by Augmedics, Ltd., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241481
Clearance Date2024-10-16
Clearance TypeTraditional
Product CodeSBF
Regulation Number882.4560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241481
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. xvision Spine System (K241481) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220905 | xvision Spine System | Augmedics, Ltd. | 2022 |
| K180523 | INTAI Surgery Navigation System | Intai Technology Corporation | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250255 | xvision Spine system | Augmedics, Ltd. | 2025 |
Trace the full predicate network for K241481
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.