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FDA 510(k)

Athena II Cervical Plate System

K-Number: K183409 · 2019-02-11

ApplicantMedyssey USA, Inc.
Decision Date2019-02-11
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Athena II Cervical Plate System is a medical device manufactured by Medyssey USA, Inc.. It received FDA 510(k) clearance on 2019-02-11 under approval number K183409. 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 II Cervical Plate System?

Athena II Cervical Plate System is a medical device that received FDA 510(k) clearance on 2019-02-11. It is manufactured by Medyssey USA, Inc.. The 510(k) number is K183409.

When was Athena II Cervical Plate System approved by the FDA?

Athena II Cervical Plate System received FDA 510(k) clearance on 2019-02-11, under approval number K183409.

What company makes Athena II Cervical Plate System?

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

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

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

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Related Devices (Code: KWQ)

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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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