Class Class II
TriALTIS™ Spine System (K242042)
Description
TriALTIS™ Spine System by Medos International SARL, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242042
Clearance Date2024-09-09
Clearance TypeTraditional
Product CodeNKB
Regulation Number888.3070
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242042
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. TriALTIS™ Spine System (K242042) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233684 | TriALTIS Spine System | Medos International SARL | 2023 |
| K231479 | TriALTIS Spine System | Medos International SARL | 2023 |
Trace the full predicate network for K242042
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.