Class Class II
REDEMPTION Charcot Plating System (K233816)
Description
REDEMPTION Charcot Plating System by Vilex, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK233816
Clearance Date2024-08-28
Clearance TypeTraditional
Product CodeHRS
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K233816
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. REDEMPTION Charcot Plating System (K233816) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230204 | ALPHALOK Plating System | Vilex, LLC | 2023 |
| K221558 | ALPHALOK Plating System | Vilex, LLC | 2022 |
| K212348 | ALPHALOK™ Plating System | Vilex, LLC | 2022 |
| K140792 | SALVATION 3DI PLATING SYSTEM | Wrightmedicaltechnologyinc | 2014 |
| K140408 | SALVATION OSTEOPENIC SCREW | Wrightmedicaltechnologyinc | 2014 |
Trace the full predicate network for K233816
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.