Cleared Traditional

EXPERT - Flexible Joint Fixation System

K242311 · GM Dos Reis Industria e Comercio Ltda. · Orthopedic
Nov 2024
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K242311 is an FDA 510(k) clearance for the EXPERT - Flexible Joint Fixation System, a Washer, Bolt Nut (Class II — Special Controls, product code HTN), submitted by GM Dos Reis Industria e Comercio Ltda. (Campinas, BR). The FDA issued a Cleared decision on November 1, 2024, 88 days after receiving the submission on August 5, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K242311 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2024
Decision Date November 01, 2024
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HTN — Washer, Bolt Nut
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030