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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 the device name listed in this FDA 510(k) record. The listed applicant is Nexxt Spine, LLC. It received FDA 510(k) clearance on 2019-05-31 under 510(k) 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. The listed applicant is Nexxt Spine, LLC. The 510(k) number is K190546.

When did NEXXT MATRIXX Stand Alone Cervical System receive FDA 510(k) clearance?

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

Who is the listed applicant for NEXXT MATRIXX Stand Alone Cervical System?

The FDA 510(k) record lists Nexxt Spine, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

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NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATION

Other records listing Nexxt Spine, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243838NEXXT MATRIXX® SI SystemK240690STRUXXURE® MCS Anterior Cervical Plate SystemK231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemK221905INERTIA CONNEXX Modular Pedicle Screw SystemK220291NEXXT SPINE NAVIGATION SystemK202230NEXXT MATRIXX Stand Alone ALIF System

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Related Devices (Code: OVE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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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