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FDA 510(k)

Athena Cervical Plate System

K-Number: K180022 · 2018-07-20

ApplicantMedyssey USA, Inc.
Decision Date2018-07-20
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Athena Cervical Plate System is a medical device manufactured by Medyssey USA, Inc.. It received FDA 510(k) clearance on 2018-07-20 under approval number K180022. 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 Athena Cervical Plate System?

Athena Cervical Plate System is a medical device that received FDA 510(k) clearance on 2018-07-20. It is manufactured by Medyssey USA, Inc.. The 510(k) number is K180022.

When was Athena Cervical Plate System approved by the FDA?

Athena Cervical Plate System received FDA 510(k) clearance on 2018-07-20, under approval number K180022.

What company makes Athena Cervical Plate System?

Athena Cervical Plate System is manufactured by Medyssey USA, Inc..

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

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

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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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