FDA 510(k)

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

K-Number: K200543 · 2020-03-23

Decision Date2020-03-23

Product CodeOVE

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System is a medical device manufactured by Nexxt Spine, LLC. It received FDA 510(k) clearance on 2020-03-23 under approval number K200543. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System?

NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System is a medical device that received FDA 510(k) clearance on 2020-03-23. It is manufactured by Nexxt Spine, LLC. The 510(k) number is K200543.

When was NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System approved by the FDA?

NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System received FDA 510(k) clearance on 2020-03-23, under approval number K200543.

What company makes NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System?

NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System is manufactured by Nexxt Spine, LLC.

What is the FDA product code for NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System?

The FDA product code for NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System is OVE.

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Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.

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.