Class Class II
Curiteva Porous PEEK Standalone ALIF System (K250845)
Description
Curiteva Porous PEEK Standalone ALIF System by Curiteva, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250845
Clearance Date2025-06-18
Clearance TypeTraditional
Product CodeOVD
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250845
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 Porous PEEK Standalone ALIF System (K250845) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233744 | Curiteva Porous PEEK Lumbar Interbody Fusion System | Curiteva, Inc. | 2024 |
| K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems | 2022 |
| K160597 | INDEPENDENCE MIS Spacers | Globus Medical, Inc. | 2016 |
Trace the full predicate network for K250845
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.