Cleared Traditional

Europa Pedicle Screw System

K192268 · MiRus, LLC · Orthopedic

Oct 2019

Decision

62d

Days

Class 2

Risk

About This 510(k) Submission

K192268 is an FDA 510(k) clearance for the Europa Pedicle Screw System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by MiRus, LLC (Marietta, US). The FDA issued a Cleared decision on October 22, 2019, 62 days after receiving the submission on August 21, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K192268 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 21, 2019
Decision Date	October 22, 2019
Days to Decision	62 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKB — Thoracolumbosacral Pedicle Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.