Class Class II
Curiteva Porous PEEK Laminoplasty System (K243137)
Description
Curiteva Porous PEEK Laminoplasty System by Curiteva, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243137
Clearance Date2024-10-28
Clearance TypeSpecial
Product CodeNQW
Regulation Number888.3050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243137
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 Laminoplasty System (K243137) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231232 | Curiteva Laminoplasty System | Curiteva, Inc. | 2023 |
| K213030 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | 2023 |
Trace the full predicate network for K243137
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.