Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Artfx Medical, LLC. It received FDA 510(k) clearance on 2022-06-28 under approval 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. It is manufactured by Artfx Medical, LLC. The 510(k) number is K211718.

When was Venus Cervical Plate System approved by the FDA?

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

What company makes Venus Cervical Plate System?

Venus Cervical Plate System is manufactured by Artfx Medical, LLC.

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

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

Related Clinical Trials

NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT07153536 Spinal Cord Stimulation Combined With Physical Therapy in Post-Stroke Upper-Limb Motor Hemiparesis RECRUITING NCT05305430 Real World Data Collection on the Synergy Cervical Disc RECRUITING NCT05880823 Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc WITHDRAWN

Other Devices by Artfx Medical, LLC

K212220ArtFX Spinal Fixation 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.

↑