Class Class II
3D Printed PEEK Interbody System (K240250)
Description
3D Printed PEEK Interbody System by Nvision Biomedical Technologies, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240250
Clearance Date2024-09-17
Clearance TypeTraditional
Product CodeMAX
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240250
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. 3D Printed PEEK Interbody System (K240250) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213030 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | 2023 |
| K193645 | nva, nvp, and nvt | Nvision Biomedical Technologies, Inc. | 2020 |
| K190380 | nvc | Nvision Biomedical Technologies, Inc. | 2019 |
Trace the full predicate network for K240250
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.