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FDA 510(k)

Venus Cervical Plate System

K-Number: K211718 · 2022-06-28

ApplicantArtfx Medical, LLC
Decision Date2022-06-28
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Venus Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Artfx Medical, LLC. It received FDA 510(k) clearance on 2022-06-28 under 510(k) number K211718. 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 Venus Cervical Plate System?

Venus Cervical Plate System is a medical device that received FDA 510(k) clearance on 2022-06-28. The listed applicant is Artfx Medical, LLC. The 510(k) number is K211718.

When did Venus Cervical Plate System receive FDA 510(k) clearance?

Venus Cervical Plate System received FDA 510(k) clearance on 2022-06-28, under 510(k) number K211718.

Who is the listed applicant for Venus Cervical Plate System?

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

What is the FDA product code for Venus Cervical Plate System?

The FDA product code for Venus Cervical Plate System is KWQ.

Other records listing Artfx Medical, LLC 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.

K242939ARTFX Trauma Bone Plate and Screw SystemK240889ARTFX Lumbar PEEK CagesK240893ARTFX MEDICAL Cervical PEEK CagesK212220ArtFX Spinal Fixation System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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