Athena Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

Medyssey USA, Inc.

The following data is part of a premarket notification filed by Medyssey Usa, Inc. with the FDA for Athena Cervical Plate System.

Pre-market Notification Details

• Device ID: K180022
• 510k Number: K180022
• Device Name: Athena Cervical Plate System
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: Medyssey USA, Inc. 1550 E. Higgins Road, Suite 123 Elk Grove Village, IL 60007
• Contact: Shawn Kim
• Correspondent: Rich Jansen; Silver Pine Consulting, LLC. 3851 Mossy Oak Drive Ft. Myers, FL 33905
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-01-03
• Decision Date: 2018-07-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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