AURORA™ Screw System

Screw, Fixation, Bone

MiRus, LLC

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

Pre-market Notification Details

• Device ID: K182989
• 510k Number: K182989
• Device Name: AURORA™ Screw System
• Classification: Screw, Fixation, Bone
• Applicant: MiRus, LLC 2150 Newmarket Parkway, Suite 108 Marietta, GA 30067
• Contact: Jordan Bauman
• Correspondent: Jordan Bauman; MiRus, LLC 2150 Newmarket Parkway, Suite 108 Marietta, GA 30067
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-10-29
• Decision Date: 2018-12-18
• Summary: summary