Cleared Traditional

Versalock Mini and Micro Plating System

K242596 · GM Dos Reis Industria e Comercio Ltda. · Orthopedic
Nov 2024
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K242596 is an FDA 510(k) clearance for the Versalock Mini and Micro 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 November 21, 2024, 83 days after receiving the submission on August 30, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K242596 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2024
Decision Date November 21, 2024
Days to Decision 83 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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