Cleared Traditional

NEXXT MATRIXX System

K193412 · Nexxt Spine, LLC · Orthopedic

Feb 2020

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K193412 is an FDA 510(k) clearance for the NEXXT MATRIXX System, a Spinal Vertebral Body Replacement Device - Cervical (Class II — Special Controls, product code PLR), submitted by Nexxt Spine, LLC (Noblesville, US). The FDA issued a Cleared decision on February 24, 2020, 77 days after receiving the submission on December 9, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number	K193412 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 09, 2019
Decision Date	February 24, 2020
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PLR — Spinal Vertebral Body Replacement Device - Cervical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3060
Definition	Vertebral Body Replacement In The Cervical Spine.