Class Class II
Omnia Medical PsiF DNA™ System (K242431)
Description
Omnia Medical PsiF DNA™ System by Omnia Medical, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242431
Clearance Date2025-06-06
Clearance TypeTraditional
Product CodeOUR
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242431
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. Omnia Medical PsiF DNA™ System (K242431) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232149 | BowTie SI Joint Fusion System | Sail Fusion, LLC | 2024 |
| K021932 | SYNTHES 6.5 MM CANNULATED SCREW | Synthes (Usa) | 2002 |
Trace the full predicate network for K242431
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.