Class Class II
NuVasive Reline System (K223181)
Description
NuVasive Reline System by Nu Vasive, Incorporated, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223181
Clearance Date2023-01-11
Clearance TypeTraditional
Product CodeNKB
Regulation Number888.3070
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223181
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. NuVasive Reline System (K223181) cites 3 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211958 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2021 |
| K190636 | NuVasive® Reline® 4.5-5.0 System | Nu Vasive, Incorporated | 2019 |
| K132014 | GSB GLOBAL SPINAL BALANCE SYSTEM | Nuvasive, Inc. | 2013 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241519 | Invictus® Small Stature Spinal Fixation System | Alphatec Spine, Inc. | 2024 |
| K232650 | KHEIRON® Spinal Fixation System, including patient specific... | S.M.A.I.O | 2023 |
Trace the full predicate network for K223181
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.