Cleared Special

Nexxt Matrixx System

K191408 · Nexxt Spine, LLC · Orthopedic

Jul 2019

Decision

43d

Days

Class 2

Risk

About This 510(k) Submission

K191408 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 July 10, 2019, 43 days after receiving the submission on May 28, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K191408 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 28, 2019
Decision Date	July 10, 2019
Days to Decision	43 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.