Iliad® Pedicle Screw System And Zenius® Pedicle Screw System

Thoracolumbosacral Pedicle Screw System

Medyssey USA, Inc.

The following data is part of a premarket notification filed by Medyssey Usa, Inc. with the FDA for Iliad® Pedicle Screw System And Zenius® Pedicle Screw System.

Pre-market Notification Details

• Device ID: K171509
• 510k Number: K171509
• Device Name: Iliad® Pedicle Screw System And Zenius® Pedicle Screw System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: Medyssey USA, Inc. 1550 East Higgins Road, Suite 123 Elk Grove Village, IL 60007
• Contact: Shawn Kim
• Correspondent: Kim Strohkirch; MRC-X, LLC 6075 Poplar Ave Memphis, TN 38119
• Product Code: NKB
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-05-23
• Decision Date: 2017-06-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08809547362686	K171509	000
08809547362679	K171509	000
08809547362662	K171509	000
08809547362655	K171509	000
08809547362648	K171509	000
08809547362631	K171509	000
08809547362624	K171509	000
08809547362617	K171509	000
08809547362600	K171509	000