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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 the device name listed in this FDA 510(k) record. The listed applicant is Medynus, Inc.. It received FDA 510(k) clearance on 2022-03-03 under 510(k) 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. The listed applicant is Medynus, Inc.. The 510(k) number is K220379.

When did IMPEACE and IMPEACE-Uni Anterior Cervical Plate System receive FDA 510(k) clearance?

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

Who is the listed applicant for IMPEACE and IMPEACE-Uni Anterior Cervical Plate System?

The FDA 510(k) record lists Medynus, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

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NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATION

Other records listing Medynus, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212792Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK CageK210420Goblin and Goblin LS Pedicle Screw Systems

Related Devices (Code: KWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLCK260015ANTERIS Thoracolumbar Plate SystemSpineCraft

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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