Cleared Special

NEXXT MATRIXX System

K200969 · Nexxt Spine, LLC · Orthopedic

May 2020

Decision

38d

Days

Class 2

Risk

About This 510(k) Submission

K200969 is an FDA 510(k) clearance for the NEXXT MATRIXX System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Nexxt Spine, LLC (Noblesville, US). The FDA issued a Cleared decision on May 21, 2020, 38 days after receiving the submission on April 13, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K200969 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 13, 2020
Decision Date	May 21, 2020
Days to Decision	38 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.