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FDA 510(k)

STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS

K-Number: K133475 · 2013-12-19

ApplicantNexxt Spine, LLC
Decision Date2013-12-19
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS 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 2013-12-19 under 510(k) number K133475. 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 ANTERIOR CERVICAL PLATE AND SCREWS?

STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS is a medical device that received FDA 510(k) clearance on 2013-12-19. The listed applicant is Nexxt Spine, LLC. The 510(k) number is K133475.

When did STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS receive FDA 510(k) clearance?

STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS received FDA 510(k) clearance on 2013-12-19, under 510(k) number K133475.

Who is the listed applicant for STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS?

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 ANTERIOR CERVICAL PLATE AND SCREWS?

The FDA product code for STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS is KWQ.

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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.

K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemK221905INERTIA CONNEXX Modular Pedicle Screw SystemK220291NEXXT SPINE NAVIGATION SystemK202230NEXXT MATRIXX Stand Alone ALIF SystemK202192STRUXXURE®-L and STRUXXURE®-A Plate SystemK200969NEXXT MATRIXX 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.

K262149corra® cervical plating systemCarlsmed, Inc.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, LLC

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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