Class Class II
Curiteva Porous PEEK Cervical Interbody Fusion System (K213030)
Description
Curiteva Porous PEEK Cervical Interbody Fusion System by Curiteva, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK213030
Clearance Date2023-02-13
Clearance TypeTraditional
Product CodeODP
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K213030
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 Cervical Interbody Fusion System (K213030) cites 3 predicate devices and is itself cited by 3 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K190025 | EVOL® -SI Joint Fusion System | Cutting Edge Spine, LLC | 2019 |
| K181261 | Curiteva Cervical Interbody Fusion System | Curiteva, LLC | 2018 |
| K173324 | ALTA Anterior Cervical Interbody Spacer | Astura Medical | 2018 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243137 | Curiteva Porous PEEK Laminoplasty System | Curiteva, Inc. | 2024 |
| K240250 | 3D Printed PEEK Interbody System | Nvision Biomedical Technologies, Inc. | 2024 |
| K233744 | Curiteva Porous PEEK Lumbar Interbody Fusion System | Curiteva, Inc. | 2024 |
Trace the full predicate network for K213030
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.