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FDA 510(k)

Lateral Plate System

K-Number: K190016 · 2019-06-12

ApplicantCorelink, LLC
Decision Date2019-06-12
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Lateral Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Corelink, LLC. It received FDA 510(k) clearance on 2019-06-12 under 510(k) number K190016. 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 Lateral Plate System?

Lateral Plate System is a medical device that received FDA 510(k) clearance on 2019-06-12. The listed applicant is Corelink, LLC. The 510(k) number is K190016.

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

Lateral Plate System received FDA 510(k) clearance on 2019-06-12, under 510(k) number K190016.

Who is the listed applicant for Lateral Plate System?

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

What is the FDA product code for Lateral Plate System?

The FDA product code for Lateral Plate System is KWQ.

Other records listing Corelink, 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.

K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate SystemK231494CoreLink Robotic Navigation InstrumentsK232116CoreLink Navigation InstrumentsK230329F3D Interbody SystemK230880CoreLink Navigation InstrumentsK223708Entasis 3D Dual-Lead Sacroiliac Implant 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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