Cleared Traditional

ATLAS Plating System

K190415 · MiRus, LLC · Orthopedic
Apr 2019
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K190415 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 19, 2019, 57 days after receiving the submission on February 21, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K190415 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2019
Decision Date April 19, 2019
Days to Decision 57 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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