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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 a medical device manufactured by Corelink, LLC. It received FDA 510(k) clearance on 2019-06-12 under approval 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. It is manufactured by Corelink, LLC. The 510(k) number is K190016.

When was Lateral Plate System approved by the FDA?

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

What company makes Lateral Plate System?

Lateral Plate System is manufactured by Corelink, LLC.

What is the FDA product code for Lateral Plate System?

The FDA product code for Lateral Plate System is KWQ.

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Other Devices by Corelink, LLC

K152237The Entasis Dual-Lead Sacroiliac Implant K163104Terrace™ Anterior Cervical Plate System K162496Foundation 3D Interbody K183239CoreLink F3D™ Lateral System K180814CoreLink® M3™ Stand-Alone Anterior Lumbar System K180556Corelink Foundation 3D Anterior Lumbar System

View all 23 devices →

Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, Inc.

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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