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FDA 510(k)

IMPEACE and IMPEACE-Uni Anterior Cervical Plate System

K-Number: K220379 · 2022-03-03

ApplicantMedynus, Inc.
Decision Date2022-03-03
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IMPEACE and IMPEACE-Uni Anterior Cervical Plate System is a medical device manufactured by Medynus, Inc.. It received FDA 510(k) clearance on 2022-03-03 under approval number K220379. 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 IMPEACE and IMPEACE-Uni Anterior Cervical Plate System?

IMPEACE and IMPEACE-Uni Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2022-03-03. It is manufactured by Medynus, Inc.. The 510(k) number is K220379.

When was IMPEACE and IMPEACE-Uni Anterior Cervical Plate System approved by the FDA?

IMPEACE and IMPEACE-Uni Anterior Cervical Plate System received FDA 510(k) clearance on 2022-03-03, under approval number K220379.

What company makes IMPEACE and IMPEACE-Uni Anterior Cervical Plate System?

IMPEACE and IMPEACE-Uni Anterior Cervical Plate System is manufactured by Medynus, Inc..

What is the FDA product code for IMPEACE and IMPEACE-Uni Anterior Cervical Plate System?

The FDA product code for IMPEACE and IMPEACE-Uni 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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