Cleared Traditional

GMReis Suture Anchors

K252664 · GM Dos Reis Industria e Comercio Ltda. · Orthopedic
Nov 2025
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K252664 is an FDA 510(k) clearance for the GMReis Suture Anchors, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by GM Dos Reis Industria e Comercio Ltda. (Campinas, BR). The FDA issued a Cleared decision on November 4, 2025, 74 days after receiving the submission on August 22, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K252664 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2025
Decision Date November 04, 2025
Days to Decision 74 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040