Class Class II
Versalock Upper Limb Plating System (K243740)
Description
Versalock Upper Limb Plating System by GM Dos Reis Industria e Comercio Ltda., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243740
Clearance Date2025-01-29
Clearance TypeTraditional
Product CodeHRS
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243740
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. Versalock Upper Limb Plating System (K243740) cites 5 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230397 | Cut Screw - Percutaneous Compression Screw | GM Dos Reis Industria e Comercio Ltda. | 2023 |
| K200332 | EXPERT - Joint Fixation System | GM Dos Reis Industria e Comercio Ltda. | 2020 |
| K182718 | Mini and Micro Fragments Reconstruction System GMReis | Gm Dos Reis Industria E Comerico Ltda. | 2019 |
| K123241 | ARTHREX FRACTURE PLATES | Arthrex, Inc. | 2013 |
| K041860 | SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG | Synthes (Usa) | 2004 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K261406 | Versalock Proximal Tibial Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026 |
Trace the full predicate network for K243740
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.