Class Class II
Helios Dura Regeneration Matrix (K250420)
Description
Helios Dura Regeneration Matrix by Helios Biomedical, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250420
Clearance Date2025-05-14
Clearance TypeTraditional
Product CodeGXQ
Regulation Number882.5910
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250420
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. Helios Dura Regeneration Matrix (K250420) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K161370 | Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2016 |
Trace the full predicate network for K250420
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.