Class Class II
OsteoCentric® UnifiMI® TCS Plating System (K251913)
Description
OsteoCentric® UnifiMI® TCS Plating System by OsteoCentric Technologies, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251913
Clearance Date2025-08-16
Clearance TypeSpecial
Product CodeHRS
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251913
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. OsteoCentric® UnifiMI® TCS Plating System (K251913) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K190430 | OsteoCentric Bone Plate and Screw System | Osteocentric Trauma | 2019 |
Trace the full predicate network for K251913
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.