Class Class II
VCFix Spinal System (K250637)
Description
VCFix Spinal System by Amber Implants, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250637
Clearance Date2025-05-30
Clearance TypeTraditional
Product CodeNDN
Regulation Number888.3027
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250637
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. VCFix Spinal System (K250637) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221697 | INJECTION PIN (KIP(02031-02061) (03031-03061)) | Slk Ortho, LLC | 2023 |
| K223294 | SpineJack® Expansion Kit | Stryker Instruments | 2022 |
| K103433 | F20 | Teknimed, S.A. | 2011 |
Trace the full predicate network for K250637
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.