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FDA 510(k)

Cyclops™ Anterior Cervical Plate System

K-Number: K191786 · 2019-08-30

ApplicantDegen Medical, Inc.
Decision Date2019-08-30
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cyclops™ Anterior Cervical Plate System is a medical device manufactured by Degen Medical, Inc.. It received FDA 510(k) clearance on 2019-08-30 under approval number K191786. 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 Cyclops™ Anterior Cervical Plate System?

Cyclops™ Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2019-08-30. It is manufactured by Degen Medical, Inc.. The 510(k) number is K191786.

When was Cyclops™ Anterior Cervical Plate System approved by the FDA?

Cyclops™ Anterior Cervical Plate System received FDA 510(k) clearance on 2019-08-30, under approval number K191786.

What company makes Cyclops™ Anterior Cervical Plate System?

Cyclops™ Anterior Cervical Plate System is manufactured by Degen Medical, Inc..

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

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

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Other Devices by Degen Medical, Inc.

K240326Solar™ Lumbar Interbody Fusion 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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