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FDA 510(k)

Anterior Cervical Plate System

K-Number: K173375 · 2017-12-21

ApplicantEvolution Spine, LLC
Decision Date2017-12-21
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Anterior Cervical Plate System is a medical device manufactured by Evolution Spine, LLC. It received FDA 510(k) clearance on 2017-12-21 under approval number K173375. 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 Anterior Cervical Plate System?

Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2017-12-21. It is manufactured by Evolution Spine, LLC. The 510(k) number is K173375.

When was Anterior Cervical Plate System approved by the FDA?

Anterior Cervical Plate System received FDA 510(k) clearance on 2017-12-21, under approval number K173375.

What company makes Anterior Cervical Plate System?

Anterior Cervical Plate System is manufactured by Evolution Spine, LLC.

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

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

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Other Devices by Evolution Spine, LLC

K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) K160324Cervical Interbody Fusion System K180755Vail ALIF Buttress Plate System K182478Whistler Modular Pedicle Screw System

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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