FDA 510(k)

CYGNUS Anterior Cervical Plate System

K-Number: K190666 · 2019-05-09

Decision Date2019-05-09

Product CodeKWQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CYGNUS Anterior Cervical Plate System is a medical device manufactured by MiRus, LLC. It received FDA 510(k) clearance on 2019-05-09 under approval number K190666. 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 CYGNUS Anterior Cervical Plate System?

CYGNUS Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2019-05-09. It is manufactured by MiRus, LLC. The 510(k) number is K190666.

When was CYGNUS Anterior Cervical Plate System approved by the FDA?

CYGNUS Anterior Cervical Plate System received FDA 510(k) clearance on 2019-05-09, under approval number K190666.

What company makes CYGNUS Anterior Cervical Plate System?

CYGNUS Anterior Cervical Plate System is manufactured by MiRus, LLC.

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

The FDA product code for CYGNUS Anterior 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.