Venus Cervical Plate System

FDA 510(k) K211718 · Artfx Medical, LLC

Substantially Equivalent

510(k) numberK211718

Submission

Device name
Venus Cervical Plate System
Applicant
Artfx Medical, LLC
Jacksonville, FL, US
Received
June 4, 2021
Decision date
June 28, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KWQ – Appliance, Fixation, Spinal Intervertebral Body
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3060
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code KWQ

510(k)DeviceApplicantDecision
K261309Palisades™ Buttress Plate SystemKWQ · Traditional Bethesda Medical Devices, LLC07/16/2026SE
K252776ARIES Anterior Cervical Plate SystemsKWQ · Traditional ZheJiang Decans Medical Devices Co., Ltd.05/14/2026SE
K261112CastleLoc-P Anterior Cervical Plate SystemKWQ · Special L&K BIOMED Co., Ltd.05/06/2026SE
K260570corra™ cervical plating systemKWQ · Traditional Carlsmed, Inc.04/22/2026SE
K260697VyPlate™ Anterior Cervical Plate SystemKWQ · Special Vy Spine, LLC03/27/2026SE
K260015ANTERIS Thoracolumbar Plate SystemKWQ · Traditional SpineCraft03/04/2026SE
K251940PathLoc Lumbar Plate SystemKWQ · Traditional L&K BIOMED Co., Ltd.03/03/2026SE
K254182AsterKWQ · Traditional Osteonic Co., Ltd.02/26/2026SE
K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)KWQ · Special 4Web, Inc.02/12/2026SE
K252611aprevo® cervical plating systemKWQ · Traditional Carlsmed, Inc.12/22/2025SE

More from Carlsmed, Inc.

510(k)DeviceDecision
K242939ARTFX Trauma Bone Plate and Screw SystemHRS · Traditional 12/23/2024SE
K240889ARTFX Lumbar PEEK CagesMAX · Traditional 10/02/2024SE
K240893ARTFX MEDICAL Cervical PEEK CagesODP · Traditional 06/28/2024SE
K212220ArtFX Spinal Fixation SystemNKB · Traditional 04/20/2023SE

Questions and answers

When was Venus Cervical Plate System cleared by the FDA?

Venus Cervical Plate System (K211718) received a 510(k) decision of Substantially Equivalent on June 28, 2022, 389 days after the submission was received.

What is the product code of K211718?

The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.