Class Class II
Altus Spine Navigation System (K243419)
Description
Altus Spine Navigation System by Altus Partners, LLC, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243419
Clearance Date2025-05-08
Clearance TypeTraditional
Product CodeOLO
Regulation Number882.4560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243419
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. Altus Spine Navigation System (K243419) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230766 | Altus Spine Monaco Pedicle Screw System | Altus Spine | 2023 |
| K181281 | Altus Spine Pedicle Screw System | Altus Partners, LLC | 2018 |
| K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments f... | Medtronic Sofamor Danek | 2017 |
Trace the full predicate network for K243419
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.