Class Class II
Stealth™ Spine Clamps; ModuLeX™ Shank Mounts (K242464)
Description
Stealth™ Spine Clamps; ModuLeX™ Shank Mounts by Medtronic Navigation, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242464
Clearance Date2025-06-05
Clearance TypeTraditional
Product CodeOLO
Regulation Number882.4560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242464
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. Stealth™ Spine Clamps; ModuLeX™ Shank Mounts (K242464) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211442 | StealthStation Spinous Process Clamps | Medtronic Navigation | 2021 |
| K131425 | NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CL... | Medtronic Navigation, Inc. | 2013 |
Trace the full predicate network for K242464
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.