Nexxt Matrixx System

Intervertebral Fusion Device With Bone Graft, Lumbar

Nexxt Spine LLC

The following data is part of a premarket notification filed by Nexxt Spine Llc with the FDA for Nexxt Matrixx System.

Pre-market Notification Details

• Device ID: K191408
• 510k Number: K191408
• Device Name: Nexxt Matrixx System
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: Nexxt Spine LLC 14425 Bergen Blvd, Suite B Noblesville, IN 46060
• Contact: Andy Elsbury
• Correspondent: Karen E Warden; BackRoads Consulting PO Box 566 Chesterland, OH 44026
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-05-28
• Decision Date: 2019-07-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840067201534	K191408	000
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