Class Class II
Mixed Reality Spine Navigation (K242569)
Description
Mixed Reality Spine Navigation by Brainlab AG, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242569
Clearance Date2025-05-16
Clearance TypeTraditional
Product CodeSBF
Regulation Number882.4560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242569
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. Mixed Reality Spine Navigation (K242569) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223290 | CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) | Sentiar, Inc. | 2023 |
| K221618 | Spine & Trauma Navigation, Spine Navigation, Navigation Sof... | Brainlab AG | 2022 |
Trace the full predicate network for K242569
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.