CYGNUS™ Anterior Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

MiRus, LLC

The following data is part of a premarket notification filed by Mirus, Llc with the FDA for Cygnus™ Anterior Cervical Plate System.

Pre-market Notification Details

• Device ID: K190666
• 510k Number: K190666
• Device Name: CYGNUS™ Anterior Cervical Plate System
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: MiRus, LLC 2150 Newmarket Parkway Marietta, GA 30067
• Contact: Jordan Bauman
• Correspondent: Jordan Bauman; MiRus, LLC 2150 Newmarket Parkway Marietta, GA 30067
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-03-15
• Decision Date: 2019-05-09