Class Class II
PediFlex™ Flexible Nail System (K251362)
Description
PediFlex™ Flexible Nail System by OrthoPediatrics Corp., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251362
Clearance Date2025-06-24
Clearance TypeTraditional
Product CodeHTY
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251362
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. PediFlex™ Flexible Nail System (K251362) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201838 | PediFlex Flexible Nail System | OrthoPediatrics Corp. | 2021 |
Trace the full predicate network for K251362
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.