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FDA 510(k)

Zevo Anterior Cervical Plate System

K-Number: K231090 · 2023-06-15

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2023-06-15
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zevo Anterior Cervical Plate System is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2023-06-15 under approval number K231090. 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 Zevo Anterior Cervical Plate System?

Zevo Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2023-06-15. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K231090.

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

Zevo Anterior Cervical Plate System received FDA 510(k) clearance on 2023-06-15, under approval number K231090.

What company makes Zevo Anterior Cervical Plate System?

Zevo Anterior Cervical Plate System is manufactured by Medtronic Sofamor Danek USA, Inc..

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

The FDA product code for Zevo Anterior 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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