Class Class II
Medyssey Navigation System (K242806)
Description
Medyssey Navigation System by Medyssey Co, Ltd., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242806
Clearance Date2025-04-16
Clearance TypeTraditional
Product CodeOLO
Regulation Number882.4560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242806
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. Medyssey Navigation System (K242806) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232218 | Zenius Spinal System | Medyssey USA, Inc. | 2023 |
| K181978 | Zenius, Iliad and Kora Spinal Fixation Systems | Medyssey USA, Inc. | 2018 |
| K124004 | NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS,... | Medtronic Navigation, Inc. | 2013 |
Trace the full predicate network for K242806
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.