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FDA 510(k)

STRUXXURE® MCS Anterior Cervical Plate System

K-Number: K240690 · 2024-03-22

ApplicantNexxt Spine
Decision Date2024-03-22
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STRUXXURE® MCS Anterior Cervical Plate System is a medical device manufactured by Nexxt Spine. It received FDA 510(k) clearance on 2024-03-22 under approval number K240690. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRUXXURE® MCS Anterior Cervical Plate System?

STRUXXURE® MCS Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2024-03-22. It is manufactured by Nexxt Spine. The 510(k) number is K240690.

When was STRUXXURE® MCS Anterior Cervical Plate System approved by the FDA?

STRUXXURE® MCS Anterior Cervical Plate System received FDA 510(k) clearance on 2024-03-22, under approval number K240690.

What company makes STRUXXURE® MCS Anterior Cervical Plate System?

STRUXXURE® MCS Anterior Cervical Plate System is manufactured by Nexxt Spine.

What is the FDA product code for STRUXXURE® MCS Anterior Cervical Plate System?

The FDA product code for STRUXXURE® MCS Anterior Cervical Plate System is KWQ.

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Other Devices by Nexxt Spine

K243838NEXXT MATRIXX® SI System

Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, 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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