Zavation EZspand Interbody System

Intervertebral Fusion Device With Bone Graft, Lumbar

Zavation Medical Products, LLC

The following data is part of a premarket notification filed by Zavation Medical Products, Llc with the FDA for Zavation Ezspand Interbody System.

Pre-market Notification Details

• Device ID: K191339
• 510k Number: K191339
• Device Name: Zavation EZspand Interbody System
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: Zavation Medical Products, LLC 220 Lakeland Parkway Flowood, MS 39232
• Contact: Matt Jones
• Correspondent: Matt Jones; Zavation Medical Products, LLC 220 Lakeland Parkway Flowood, MS 39232
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-05-20
• Decision Date: 2019-08-19

NIH GUDID Devices

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