Class Class II
Huvex Interspinous Fusion System (K223790)
Description
Huvex Interspinous Fusion System by Dio Medical Corp., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223790
Clearance Date2023-03-09
Clearance TypeTraditional
Product CodePEK
Regulation Number888.3050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223790
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. Huvex Interspinous Fusion System (K223790) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K162849 | Huvex Interspinous Fixation System | Dio Medical Co., Ltd. | 2017 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232877 | FaSet Fixation System, UNITY Sacroiliac Joint Fixation Syst... | K&J Consulting Corporation | 2023 |
Trace the full predicate network for K223790
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.