Class Class II
GMReis Suture Anchors (K252664)
Description
GMReis Suture Anchors by GM Dos Reis Industria e Comercio Ltda., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK252664
Clearance Date2025-11-04
Clearance TypeTraditional
Product CodeMBI
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K252664
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. GMReis Suture Anchors (K252664) cites 0 predicate devices and is itself cited by 1 later device.
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K254188 | Meniscus Versaflex | GM Dos Reis Industria e Comercio Ltda. | 2026 |
Trace the full predicate network for K252664
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.