Class Class II
EUROSCREW NG; EUROSCREW TCP NG (K230394)
Description
EUROSCREW NG; EUROSCREW TCP NG by Teknimed, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230394
Clearance Date2023-05-12
Clearance TypeTraditional
Product CodeMAI
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230394
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. EUROSCREW NG; EUROSCREW TCP NG (K230394) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K122228 | LIGAFIX INTERFERENCE SCREW | Sbm Sciences For Bio Materials | 2012 |
Trace the full predicate network for K230394
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.