Cleared Traditional

NEXXT MATRIXX Stand Alone Cervical System

K190546 · Nexxt Spine, LLC · Orthopedic

May 2019

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K190546 is an FDA 510(k) clearance for the NEXXT MATRIXX Stand Alone Cervical System, a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II — Special Controls, product code OVE), submitted by Nexxt Spine, LLC (Noblesville, US). The FDA issued a Cleared decision on May 31, 2019, 87 days after receiving the submission on March 5, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K190546 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 05, 2019
Decision Date	May 31, 2019
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

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