Cleared Traditional

NEXXT MATRIXX Stand Alone ALIF System

K202230 · Nexxt Spine, LLC · Orthopedic

Dec 2020

Decision

130d

Days

Class 2

Risk

About This 510(k) Submission

K202230 is an FDA 510(k) clearance for the NEXXT MATRIXX Stand Alone ALIF System, a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II — Special Controls, product code OVD), submitted by Nexxt Spine, LLC (Noblesville, US). The FDA issued a Cleared decision on December 15, 2020, 130 days after receiving the submission on August 7, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K202230 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 07, 2020
Decision Date	December 15, 2020
Days to Decision	130 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.