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FDA 510(k)

NEXXT MATRIXX® SI System

K-Number: K243838 · 2025-03-14

ApplicantNexxt Spine
Decision Date2025-03-14
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEXXT MATRIXX® SI System is the device name listed in this FDA 510(k) record. The listed applicant is Nexxt Spine. It received FDA 510(k) clearance on 2025-03-14 under 510(k) number K243838. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEXXT MATRIXX® SI System?

NEXXT MATRIXX® SI System is a medical device that received FDA 510(k) clearance on 2025-03-14. The listed applicant is Nexxt Spine. The 510(k) number is K243838.

When did NEXXT MATRIXX® SI System receive FDA 510(k) clearance?

NEXXT MATRIXX® SI System received FDA 510(k) clearance on 2025-03-14, under 510(k) number K243838.

Who is the listed applicant for NEXXT MATRIXX® SI System?

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

What is the FDA product code for NEXXT MATRIXX® SI System?

The FDA product code for NEXXT MATRIXX® SI System is OUR.

Other records listing Nexxt Spine 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.

K240690STRUXXURE® MCS Anterior Cervical Plate SystemK231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemK221905INERTIA CONNEXX Modular Pedicle Screw SystemK220291NEXXT SPINE NAVIGATION SystemK202230NEXXT MATRIXX Stand Alone ALIF SystemK202192STRUXXURE®-L and STRUXXURE®-A Plate System

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Related Devices (Code: OUR)

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.

K260477CATAMARAN™ SI Joint Fusion SystemTenon MedicalK253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.K253611Falco Fusion SystemMcnicoll Surgical, Inc.K252834Sacroiliac Joint Truss System (SJTS)4Web MedicalK251365OptumSI Implant SystemSi Solutions, LLCK252322SIros-X SystemGenesys 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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