Class Class II
NuVasive Pulse System (K243814)
Description
NuVasive Pulse System by Globus Medical, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243814
Clearance Date2025-01-10
Clearance TypeSpecial
Product CodeOLO
Regulation Number882.4560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243814
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 Pulse System (K243814) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210574 | NuVasive Pulse System | Nu Vasive, Incorporated | 2021 |
| K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. | 2019 |
| K171651 | EXCELSIUS GPS | Globus Medical, Inc. | 2017 |
Trace the full predicate network for K243814
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.