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FDA 510(k)

STRUXXURE®-L and STRUXXURE®-A Plate System

K-Number: K202192 · 2020-09-17

ApplicantNexxt Spine, LLC
Decision Date2020-09-17
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STRUXXURE®-L and STRUXXURE®-A Plate 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 2020-09-17 under 510(k) number K202192. 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®-L and STRUXXURE®-A Plate System?

STRUXXURE®-L and STRUXXURE®-A Plate System is a medical device that received FDA 510(k) clearance on 2020-09-17. The listed applicant is Nexxt Spine, LLC. The 510(k) number is K202192.

When did STRUXXURE®-L and STRUXXURE®-A Plate System receive FDA 510(k) clearance?

STRUXXURE®-L and STRUXXURE®-A Plate System received FDA 510(k) clearance on 2020-09-17, under 510(k) number K202192.

Who is the listed applicant for STRUXXURE®-L and STRUXXURE®-A Plate 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 STRUXXURE®-L and STRUXXURE®-A Plate System?

The FDA product code for STRUXXURE®-L and STRUXXURE®-A Plate System is KWQ.

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: KWQ)

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.

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLCK260015ANTERIS Thoracolumbar Plate SystemSpineCraft

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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