Class Class II
ALPHALOK Plating System (K230204)
Description
ALPHALOK Plating System by Vilex, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230204
Clearance Date2023-04-25
Clearance TypeTraditional
Product CodeHRS
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230204
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. ALPHALOK Plating System (K230204) cites 3 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221558 | ALPHALOK Plating System | Vilex, LLC | 2022 |
| K212348 | ALPHALOKâ„¢ Plating System | Vilex, LLC | 2022 |
| K163044 | ORTHOLOC® 3Di Ankle Fracture Plating System | Wrightmedicaltechnologyinc | 2017 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243408 | TACTIX Vector Syndesmosis System | Vilex, LLC | 2024 |
| K233816 | REDEMPTION Charcot Plating System | Vilex, LLC | 2024 |
Trace the full predicate network for K230204
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.