Class Class II
ARTFX Lumbar PEEK Cages (K240889)
Description
ARTFX Lumbar PEEK Cages by Artfx Medical, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240889
Clearance Date2024-10-02
Clearance TypeTraditional
Product CodeMAX
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240889
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. ARTFX Lumbar PEEK Cages (K240889) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K180078 | Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF Sy... | Innovasis, Inc. | 2018 |
| K152011 | Lucent Intervertebral Body Fusion Device | Spinal Elements, Inc. | 2016 |
Trace the full predicate network for K240889
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.