Class Class II
Impact PEEK Union Nail System (K250646)
Description
Impact PEEK Union Nail System by Nvision Biomedical Technologies, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250646
Clearance Date2025-06-11
Clearance TypeTraditional
Product CodeHTY
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250646
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. Impact PEEK Union Nail System (K250646) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K181180 | OSSIO™ Pin Product Family | OSSIO , Ltd. | 2019 |
| K133932 | INION FREEDOMPIN | Inion OY | 2014 |
Trace the full predicate network for K250646
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.