EUROPA™ Pedicle Screw System

Thoracolumbosacral Pedicle Screw System

MiRus, LLC

The following data is part of a premarket notification filed by Mirus, Llc with the FDA for Europa™ Pedicle Screw System.

Pre-market Notification Details

• Device ID: K182970
• 510k Number: K182970
• Device Name: EUROPA™ Pedicle Screw System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: MiRus, LLC 2150 Newmarket Parkway, Suite 108 Marietta, GA 30067
• Contact: Jordan Bauman
• Correspondent: Jordan Bauman; MiRus, LLC 2150 Newmarket Parkway SE, Suite 108 Marietta, GA 30067
• Product Code: NKB
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-10-26
• Decision Date: 2019-01-22
• Summary: summary