Class Class II
VOLT™ Proximal Humerus 3.5 Plating System (K233994)
Description
VOLT™ Proximal Humerus 3.5 Plating System by Synthes GmbH, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK233994
Clearance Date2024-07-26
Clearance TypeTraditional
Product CodeHRS
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K233994
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. VOLT™ Proximal Humerus 3.5 Plating System (K233994) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233665 | DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synt... | DePuy Synthes | 2024 |
| K041860 | SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG | Synthes (Usa) | 2004 |
Trace the full predicate network for K233994
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.