Cleared Traditional

Versalock Upper Limb Plating System

K243740 · GM Dos Reis Industria e Comercio Ltda. · Orthopedic
Jan 2025
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K243740 is an FDA 510(k) clearance for the Versalock Upper Limb Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by GM Dos Reis Industria e Comercio Ltda. (Campinas, BR). The FDA issued a Cleared decision on January 29, 2025, 56 days after receiving the submission on December 4, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K243740 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2024
Decision Date January 29, 2025
Days to Decision 56 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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