Cleared Traditional

ATLAS Plating System

K191867 · MiRus, LLC · Orthopedic
Apr 2020
Decision
272d
Days
Class 2
Risk

About This 510(k) Submission

K191867 is an FDA 510(k) clearance for the ATLAS Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by MiRus, LLC (Marietta, US). The FDA issued a Cleared decision on April 9, 2020, 272 days after receiving the submission on July 12, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K191867 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 2019
Decision Date April 09, 2020
Days to Decision 272 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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