Class Class II
Cervical Spine Truss System (CSTS) (K251117)
Description
Cervical Spine Truss System (CSTS) by 4Web Medical, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251117
Clearance Date2025-04-25
Clearance TypeSpecial
Product CodeOVE
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251117
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. Cervical Spine Truss System (CSTS) (K251117) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231739 | Cervical Spine Truss System (CSTS) | 4Web Medical, Inc. | 2023 |
| K203065 | Lumbar Spine Truss System Plating Solution (LSTS-PS) | 4Web, Inc. | 2021 |
Trace the full predicate network for K251117
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.