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FDA 510(k)

Transept Cervical Plate System

K-Number: K200927 · 2020-07-24

ApplicantNeurostructures, Inc.
Decision Date2020-07-24
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Transept Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Neurostructures, Inc.. It received FDA 510(k) clearance on 2020-07-24 under 510(k) number K200927. 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 Transept Cervical Plate System?

Transept Cervical Plate System is a medical device that received FDA 510(k) clearance on 2020-07-24. The listed applicant is Neurostructures, Inc.. The 510(k) number is K200927.

When did Transept Cervical Plate System receive FDA 510(k) clearance?

Transept Cervical Plate System received FDA 510(k) clearance on 2020-07-24, under 510(k) number K200927.

Who is the listed applicant for Transept Cervical Plate System?

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

What is the FDA product code for Transept Cervical Plate System?

The FDA product code for Transept Cervical Plate System is KWQ.

Other records listing Neurostructures, Inc. 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.

K202190Oculus-SA Lumbar Cage SystemK200115Cavetto-SA Cervical Cage SystemK201769Cavetto [MAX] Cervical Cage SystemK192248Cortina™ [MAX] Lumbar Cage SystemK182195Arco™-SA Lumbar Cage SystemK181590Neurostructures Cavetto® [MAX] Cervical Cage 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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