Varian Cage

Intervertebral Fusion Device With Bone Graft, Lumbar

Medyssey USA, Inc.

The following data is part of a premarket notification filed by Medyssey Usa, Inc. with the FDA for Varian Cage.

Pre-market Notification Details

• Device ID: K172756
• 510k Number: K172756
• Device Name: Varian Cage
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: Medyssey USA, Inc. 1550 E. Higgins Road, Suite 123 Elk Grove Village, IL 60007
• Contact: Shawn Kim
• Correspondent: Justin Eggleton; Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW Suite 1000 Washington, DC 20001
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-09-13
• Decision Date: 2017-12-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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