Cleared Special

NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System

K200543 · Nexxt Spine, LLC · Orthopedic

Mar 2020

Decision

20d

Days

Class 2

Risk

About This 510(k) Submission

K200543 is an FDA 510(k) clearance for the NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) 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 March 23, 2020, 20 days after receiving the submission on March 3, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K200543 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 03, 2020
Decision Date	March 23, 2020
Days to Decision	20 days
Submission Type	Special
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.