FDA 510(k)

CYGNUS MoRe Anterior Cervical Plate System

K-Number: K220441 · 2022-09-16

Decision Date2022-09-16

Product CodeKWQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CYGNUS MoRe Anterior Cervical Plate System is a medical device manufactured by MiRus, LLC. It received FDA 510(k) clearance on 2022-09-16 under approval number K220441. 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 MoRe Anterior Cervical Plate System?

CYGNUS MoRe Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2022-09-16. It is manufactured by MiRus, LLC. The 510(k) number is K220441.

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

CYGNUS MoRe Anterior Cervical Plate System received FDA 510(k) clearance on 2022-09-16, under approval number K220441.

What company makes CYGNUS MoRe Anterior Cervical Plate System?

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

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

The FDA product code for CYGNUS MoRe 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.