Class Class II
Curiteva Navigation System (K223200)
Description
Curiteva Navigation System by Curiteva, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223200
Clearance Date2023-01-06
Clearance TypeTraditional
Product CodeOLO
Regulation Number882.4560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223200
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. Curiteva Navigation System (K223200) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K161210 | RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments... | Medtronic Sofamor Danek | 2016 |
| K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable Inst... | Medtronic Sofamor Danek USA, Inc. | 2015 |
| K143628 | Navigated Vertex Select Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 |
| K140454 | NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS | Medtronic Sofamor Danek USA, Inc. | 2014 |
Trace the full predicate network for K223200
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.