FDA 510(k)

NEXXT MATRIXX System

K-Number: K193412 · 2020-02-24

Decision Date2020-02-24

Product CodePLR

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

NEXXT MATRIXX System is a medical device manufactured by Nexxt Spine, LLC. It received FDA 510(k) clearance on 2020-02-24 under approval number K193412. The device is classified under product code PLR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEXXT MATRIXX System?

NEXXT MATRIXX System is a medical device that received FDA 510(k) clearance on 2020-02-24. It is manufactured by Nexxt Spine, LLC. The 510(k) number is K193412.

When was NEXXT MATRIXX System approved by the FDA?

NEXXT MATRIXX System received FDA 510(k) clearance on 2020-02-24, under approval number K193412.

What company makes NEXXT MATRIXX System?

NEXXT MATRIXX System is manufactured by Nexxt Spine, LLC.

What is the FDA product code for NEXXT MATRIXX System?

The FDA product code for NEXXT MATRIXX System is PLR.

Other Devices by Nexxt Spine, LLC

K153453Inertia Pedicle Screw and Deformity Correxxion System K171140Matrixx System K182508Saxxony Posterior Cervical Thoracic System K191408Nexxt Matrixx System K190546NEXXT MATRIXX Stand Alone Cervical System K202230NEXXT MATRIXX Stand Alone ALIF System

View all 15 devices →

Related Devices (Code: PLR)

K152568C-VBRCardinal Spine, LLC K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc. K180550NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated K173893TrabisColigne AG K180673Normandy VBR SystemZavation Medical Products, LLC K190284Bengal Stackable Cage SystemMedos International SARL

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.