Cleared Traditional

MiRus MoRe Lumbar Plating System

K241175 · MiRus, LLC · Orthopedic
May 2024
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K241175 is an FDA 510(k) clearance for the MiRus MoRe Lumbar Plating System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by MiRus, LLC (Marietta, US). The FDA issued a Cleared decision on May 17, 2024, 21 days after receiving the submission on April 26, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K241175 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2024
Decision Date May 17, 2024
Days to Decision 21 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

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