Class Class II
Cortium™ (K230614)
Description
Cortium™ by Ulrich Medical USA, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230614
Clearance Date2023-05-02
Clearance TypeTraditional
Product CodeNKG
Regulation Number888.3075
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230614
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. Cortium™ (K230614) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K161032 | neon3 universal OCT spinal stabilization | Ulrich GmbH & Co. KG | 2016 |
| K150650 | neon3 | Ulrich GmbH & Co. KG | 2015 |
| K113346 | NEON SYSTEM | Ulrich GmbH & Co. KG | 2012 |
Trace the full predicate network for K230614
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.