FDA 510(k)

EUROPA Posterior Cervical Fusion System

K-Number: K242516 · 2024-11-19

Decision Date2024-11-19

Product CodeNKG

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

EUROPA Posterior Cervical Fusion System is a medical device manufactured by MiRus, LLC. It received FDA 510(k) clearance on 2024-11-19 under approval number K242516. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUROPA Posterior Cervical Fusion System?

EUROPA Posterior Cervical Fusion System is a medical device that received FDA 510(k) clearance on 2024-11-19. It is manufactured by MiRus, LLC. The 510(k) number is K242516.

When was EUROPA Posterior Cervical Fusion System approved by the FDA?

EUROPA Posterior Cervical Fusion System received FDA 510(k) clearance on 2024-11-19, under approval number K242516.

What company makes EUROPA Posterior Cervical Fusion System?

EUROPA Posterior Cervical Fusion System is manufactured by MiRus, LLC.

What is the FDA product code for EUROPA Posterior Cervical Fusion System?

The FDA product code for EUROPA Posterior Cervical Fusion System is NKG.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Other Devices by MiRus, LLC

K182989AURORA Screw System K192268Europa Pedicle Screw System K191757EUROPA Pedicle Screw System K182524GALILEO Spine Alignment Monitoring System K190618RIGEL PEEK Anterior Cervical Interbody Fusion System K190666CYGNUS Anterior Cervical Plate System

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Related Devices (Code: NKG)

K161032neon3 universal OCT spinal stabilizationUlrich GmbH & Co. KG K162300Reform® POCT SystemPrecision Spine, Inc. K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. K161591QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. K161478Xenco Medical Posterior Cervical SystemXenco Medical, LLC K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, 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.