Class Class II
SABER-C System (K250540)
Description
SABER-C System by Elevation Spine, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250540
Clearance Date2025-08-08
Clearance TypeTraditional
Product CodeOVE
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250540
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. SABER-C System (K250540) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K191243 | HEDRON Cervical Spacers | Globus Medical, Inc. | 2019 |
| K190885 | Elevation Spine Saber-C System | Elevation Spine | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250402 | AVAVA Skin Treatment System | AVAVA, Inc. | 2025 |
Trace the full predicate network for K250540
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.