Class Class II
Virata Spinal Fixation System (K250908)
Description
Virata Spinal Fixation System by SeaSpine Orthopedics Corporation, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250908
Clearance Date2025-06-18
Clearance TypeTraditional
Product CodeNKB
Regulation Number888.3070
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250908
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. Virata Spinal Fixation System (K250908) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222110 | Mariner RDX System | SeaSpine Orthopedics Corporation | 2022 |
| K172517 | SeaSpine Navigation System | SeaSpine Orthopedics Corporation | 2018 |
| K132014 | GSB GLOBAL SPINAL BALANCE SYSTEM | Nuvasive, Inc. | 2013 |
Trace the full predicate network for K250908
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.