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FDA 510(k)

VyPlate™ Anterior Cervical Plate System

K-Number: K260697 · 2026-03-27

ApplicantVy Spine, LLC
Decision Date2026-03-27
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VyPlate™ Anterior Cervical Plate System is a medical device manufactured by Vy Spine, LLC. It received FDA 510(k) clearance on 2026-03-27 under approval number K260697. 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 VyPlate™ Anterior Cervical Plate System?

VyPlate™ Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2026-03-27. It is manufactured by Vy Spine, LLC. The 510(k) number is K260697.

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

VyPlate™ Anterior Cervical Plate System received FDA 510(k) clearance on 2026-03-27, under approval number K260697.

What company makes VyPlate™ Anterior Cervical Plate System?

VyPlate™ Anterior Cervical Plate System is manufactured by Vy Spine, LLC.

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

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

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Other Devices by Vy Spine, LLC

K213219Vy Spine™ VyWasher™ Buttress System K212715Vy Spine ClariVy Cervical IBF System K213394Vy Spine™ VySpan™ PCT System K221162UniVy OsteoVy Cervical IBF System K221572VyPlate Anterior Cervical Plate System K213750VyLink™ Spinal Screw System

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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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