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FDA 510(k)

Terrace™ Anterior Cervical Plate System

K-Number: K163104 · 2017-06-21

ApplicantCorelink, LLC
Decision Date2017-06-21
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Terrace™ Anterior Cervical Plate System is a medical device manufactured by Corelink, LLC. It received FDA 510(k) clearance on 2017-06-21 under approval number K163104. 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 Terrace™ Anterior Cervical Plate System?

Terrace™ Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2017-06-21. It is manufactured by Corelink, LLC. The 510(k) number is K163104.

When was Terrace™ Anterior Cervical Plate System approved by the FDA?

Terrace™ Anterior Cervical Plate System received FDA 510(k) clearance on 2017-06-21, under approval number K163104.

What company makes Terrace™ Anterior Cervical Plate System?

Terrace™ Anterior Cervical Plate System is manufactured by Corelink, LLC.

What is the FDA product code for Terrace™ Anterior Cervical Plate System?

The FDA product code for Terrace™ Anterior Cervical Plate System is KWQ.

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Other Devices by Corelink, LLC

K152237The Entasis Dual-Lead Sacroiliac Implant K162496Foundation 3D Interbody K183239CoreLink F3D™ Lateral System K180814CoreLink® M3™ Stand-Alone Anterior Lumbar System K180556Corelink Foundation 3D Anterior Lumbar System K182731Corelink Navigation Instruments

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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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