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FDA 510(k)

Cervical Plate System

K-Number: K201979 · 2020-08-25

ApplicantEminent Spine, LLC
Decision Date2020-08-25
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Eminent Spine, LLC. It received FDA 510(k) clearance on 2020-08-25 under 510(k) number K201979. 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 Cervical Plate System?

Cervical Plate System is a medical device that received FDA 510(k) clearance on 2020-08-25. The listed applicant is Eminent Spine, LLC. The 510(k) number is K201979.

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

Cervical Plate System received FDA 510(k) clearance on 2020-08-25, under 510(k) number K201979.

Who is the listed applicant for Cervical Plate System?

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

What is the FDA product code for Cervical Plate System?

The FDA product code for Cervical Plate System is KWQ.

Other records listing Eminent 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.

K250894Eminent Spine Posterior SI SystemK241663Eminent Spine 3D Titanium Pedicle Screw SystemK242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemK240505Eminent Spine SI Screw SystemK230219Eminent Spine 3D Lumbar Interbody Fusion SystemsK212701Eminent Spine 3D Cervical Interbody Fusion 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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