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FDA 510(k)

NEXXT MATRIXX Stand Alone Cervical System

K-Number: K190546 · 2019-05-31

ApplicantNexxt Spine, LLC
Decision Date2019-05-31
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEXXT MATRIXX Stand Alone Cervical System is a medical device manufactured by Nexxt Spine, LLC. It received FDA 510(k) clearance on 2019-05-31 under approval number K190546. 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 System?

NEXXT MATRIXX Stand Alone Cervical System is a medical device that received FDA 510(k) clearance on 2019-05-31. It is manufactured by Nexxt Spine, LLC. The 510(k) number is K190546.

When was NEXXT MATRIXX Stand Alone Cervical System approved by the FDA?

NEXXT MATRIXX Stand Alone Cervical System received FDA 510(k) clearance on 2019-05-31, under approval number K190546.

What company makes NEXXT MATRIXX Stand Alone Cervical System?

NEXXT MATRIXX Stand Alone Cervical System is manufactured by Nexxt Spine, LLC.

What is the FDA product code for NEXXT MATRIXX Stand Alone Cervical System?

The FDA product code for NEXXT MATRIXX Stand Alone Cervical System is OVE.

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Other Devices by Nexxt Spine, LLC

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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.

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