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FDA 510(k)

NexGen Anterior Cervical Plate System

K-Number: K192494 · 2019-10-29

ApplicantPrecision Spine
Decision Date2019-10-29
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NexGen Anterior Cervical Plate System is a medical device manufactured by Precision Spine. It received FDA 510(k) clearance on 2019-10-29 under approval number K192494. 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 NexGen Anterior Cervical Plate System?

NexGen Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2019-10-29. It is manufactured by Precision Spine. The 510(k) number is K192494.

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

NexGen Anterior Cervical Plate System received FDA 510(k) clearance on 2019-10-29, under approval number K192494.

What company makes NexGen Anterior Cervical Plate System?

NexGen Anterior Cervical Plate System is manufactured by Precision Spine.

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

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

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Other Devices by Precision Spine

K200303Reform Pedicle Screw 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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